[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Exeter\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":548},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,45,76,106,138,166,195,227,252,270,287,308,336,361,383,403,430,461,486,525],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100637747","the-feasibility-and-acceptability-of-a-gait-training-program-based-on-telerehabilitation-after-stroke-100637747",false,"NCT07623018","The Feasibility and Acceptability of a Gait Training Program Based on Telerehabilitation After Stroke","What is the Feasibility and Patient Acceptability of a Gait Training Program Based on Telerehabilitation After Stroke? A Mixed-methods, Single-arm Feasibility Study of the (STEP-Tech) Intervention","Inclusion Criteria:\n\nFor stage one of the study:\n\n* People with stroke aged \\> 18 years living in Saudi Arabia.\n* Diagnosed with ischemic or haemorrhagic stroke.\n* People with stroke in the late-subacute or chronic phase ( ≥ 3 months after stroke onset).\n* Patients can walk indoors for at least 10 meters with supervision and\u002For an assistive device (cane or walker).\n* Patient with low fall risk (less than 20 seconds) based on the Timed Up and Go test (TUG).\n* Ability to understand instructions and follow simple commands to participate in the study and give consent. Patients are required to obtain a score of seven or eight on the eight decisional capacity questionnaires that are relevant to the consent form content. These requirements are necessary to make sure that people can give consent. The decisional capacity questionnaire's content is based on the previously utilised University of California Brief Assessment Capacity to Consent (UBACC) questions that have been adjusted for the study's context.\n* They are not currently participating in any other stroke rehabilitation study.\n* Only those who can speak Arabic or English.\n\nFor stage 2 of the study (qualitative evaluation):\n\n* Physiotherapists with experience working with people who have had a stroke (at least 2 years of experience).\n* Carers aged 18 years or older who support patients during the intervention period\n* Able to communicate in Arabic or English\n\nExclusion Criteria:\n\nFor stage one of the study :\n\n* Patient with severe spasticity and contracture in the lower extremity (Modified Ashworth Scale 3 or 4).\n* Unable to understand instructions to participate in the study and to give consent (due to severe cognitive impairments).\n* Severe communication deficit or complete aphasia.\n* Patients have another neurological condition (e.g., multiple sclerosis or Parkinson's disease) or a pre-stroke health condition that includes a gait disorder.\n* Serious medical comorbidities such as pulmonary and heart disease, and uncontrolled hypertension.\n\nFor stage 2 of the study (qualitative evaluation):\n\n* Physiotherapists with insufficient experience (less than 2 years' experience) in stroke rehabilitation.\n* Carers who are unable to communicate well or have communication difficulties.\n* Carers who are unable to give consent.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"NA","Gait impairments following stroke significantly reduce functional mobility, making walking recovery a primary rehabilitation goal to improve safety, speed, and quality of life while reducing fall risk. Delivering interventions at home via technology can enhance adherence to home exercise programmes and increase therapy frequency and intensity. This study aims to determine the feasibility and acceptability of the Stroke Telerehabilitation for Enhanced Performance in Gait via Technology (STEP-Tech) intervention for patients with stroke in Saudi Arabia. The intervention will be delivered by trained physiotherapists in two phases. Phase one will take place in an outpatient setting, during which patients may require approximately three sessions over one week. Phase two will be home-based for four weeks.",[26],"Stroke",[28,29,30,31],"stroke","Telerehabilitation","Gait","Feasibility study","NOT_YET_RECRUITING","2026-06-01",{"date":35,"type":36},"2026-06-03","ACTUAL",{"date":38,"type":20},"2027-08-01",{"date":40,"type":20},"2028-08-01",{"name":42,"class":43},"University of Exeter","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100637329","physical-activity-during-pregnancy-in-women-with-pre-existing-diabetes-100637329","NCT07581106","Physical Activity During Pregnancy in Women With Pre-existing Diabetes","Physical Activity During Pregnancy in Women With Pre-existing Diabetes, Support Needs, and Associations With Diabetes Management and Mental Health","PA-DIP","Inclusion Criteria:\n\n* Women between 8 - 20 weeks pregnant (this will allow completion of at least two measures during pregnancy)\n* Singleton pregnancy\n* Confirmed diagnosis of T1D or T2D\n* Over 18 years old\n* Willing and able to provide informed consent\n* Receiving care at one of the participating NHS sites\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Absolute contra-indication to PA according to 2019 Canadian Guidelines for physical activity during pregnancy , examples include ruptured membranes, preeclampsia and intrauterine growth restriction, full list available here37\n* No diagnoses of T1D or T2D prior to pregnancy\n* Gestational Diabetes","FEMALE",{"count":55,"type":20},175,"OBSERVATIONAL","Pregnancy can be more challenging for women with pre-existing (Type 1 or Type 2 diabetes) because it increases the risk of complications such as early births or babies being born larger than usual. Keeping blood sugar levels under control is very important to reduce these risks but the hormonal changes that happen during pregnancy make this harder to manage and can cause added stress for expectant mothers. There have been improvements in technology to monitor and manage blood sugar levels, however, there have not been many improvements in pregnancy outcomes in this population Physical activity and exercise during pregnancy have many benefits such as cardiovascular health and lower chance of pregnancy complications. For individuals with diabetes, physical activity can also help manage blood sugar levels and reduce insulin requirements. However, there is limited research on physical activity in women with pre-existing diabetes.\n\nThis study aims to find out how physical activity levels change throughout pregnancy, and how physical activity may be linked to blood sugar levels and diabetes related mental health. To determine what needs to be improved regarding physical activity during pregnancy in diabetes, it is crucial to first understand what activity patterns women engage in throughout pregnancy. In addition, what support is needed and when, will be explored Pregnant women (aged 18years or older) with a diagnosis of type 1 or type 2 diabetes before becoming pregnant will be invited to take part. Participants will be recruited during routine clinic visits.\n\nPhysical activity during pregnancy in women with pre-existing diabetes will be explored using both measurable activity data and patient experiences of being physically activity during pregnancy. Pregnant women with pre-existing diabetes will be invited to take part from early in their pregnancy. Participants will wear a wrist-based activity monitor for seven days in each trimester, complete an exercise diary and record meals through remote food photography during this time. At the end of each monitoring period, they will complete a questionnaire on diabetes-related emotional distress. Participants will share their continuous glucose monitor and insulin pump data (if applicable), with permission, through the online platforms they normally use to share data with their healthcare team.\n\nParticipants will have the option to join a focus group which will be held online via a video conferencing service (e.g.Zoom). This will involve group discussions will be audio recorded, and cover topics including experiences and feelings about physical activity, and what support regarding physical activity would they find useful.\n\nThere are no direct health benefits for participants, but the study may help improve future guidance and support for women with diabetes during pregnancy.\n\nThis study involves minimal risks. It requires no change in usual treatment or care, no additional clinical visits over and above those routinely scheduled, and no changes in usual behaviour. Within the observational study, there is a small risk of discomfort from wearing the activity monitor for seven days, if this becomes severe irritation, the participant will be informed they can remove the monitor and contact the research team. When conducting the focus groups there is a risk that some topics may bring out discussions which are sensitive, and the potential for participants being upset by something another participant may have said. If participants feel upset by participation in the focus group, they will be made aware they can leave at any time, and participants will directed to further support if required.",[59,60],"Diabetes","Pregnancy",[62,63,64,65,60,66,67],"Physical Activity","Pre-existing diabetes","Type 1 Diabetes","Type 2 Diabetes","Mental Health","Diabetes Distress","2026-05-06",{"date":70,"type":36},"2026-05-12",{"date":72,"type":20},"2026-05-11",{"date":74,"type":20},"2027-09-24",{"name":42,"class":43},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":16,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100636799","biomarkers-of-asdadhd-and-factors-affecting-anxiety-and-depression-in-children-and-young-adults-100636799","NCT07570381","Biomarkers of ASD\u002FADHD and Factors Affecting Anxiety and Depression in Children and Young Adults","Biomarker Discovery for Predicting Autism Spectrum Disorder and Attention\u002FHyperactivity Disorders, and Identification of Environmental Factors Influencing Anxiety and Depression in Children, Adolescents, and Young Adults","PUREMIND-OS","OS1 Inclusion Criteria:\n\n* Infants born very preterm (\\\u003C32 weeks) or extremely preterm (\\\u003C28 weeks); or\n* Term-born infants with documented perinatal asphyxia and hypoxic-ischaemic encephalopathy (HIE); or\n* Term-born infants with no risk factors (comparison group).\n* Must be ≤12 months corrected age at enrolment.\n\nOS1 Exclusion Criteria:\n\n* Syndromic, chromosomal, or known genetic conditions.\n* Motor impairments that would prevent participation in psychometric or neurophysiology assessments.\n\nOS2 Inclusion Criteria:\n\n* Individuals aged 5-25 years.\n* Clinical diagnosis of ASD, ADHD, or Developmental Coordination Disorder (DCD).\n* Able to participate in scheduled assessments.\n\nOS2 Exclusion Criteria:\n\n* Severe motor impairments that limit psychometric assessment.\n* Diagnosis of schizophrenia, due to confounding neurocognitive effects.",true,"6 Months","25 Years",{"count":88,"type":20},800,"The PUREMIND OS1\u002FOS2 study is a multinational, prospective, longitudinal observational study designed to identify early neurophysiological, biological, environmental, and psychosocial markers associated with neurodevelopmental and mental health conditions from infancy through young adulthood.\n\nObservational Study 1 (OS1) follows infants and toddlers at high risk for Autism Spectrum Disorder (ASD) and Attention-Deficit\u002FHyperactivity Disorder (ADHD) to discover biomarkers predictive of later clinical diagnosis, using EEG, fNIRS, psychometric assessments, and biological samples.\n\nObservational Study 2 (OS2) includes children, adolescents, and young adults with ASD, ADHD, or Developmental Coordination Disorder (DCD) to identify environmental and biological factors causally linked to anxiety and depression symptoms, and to support the development of personalised criteria for evidence-based interventions.\n\nApproximately 800 participants will be recruited across 10 international clinical sites. The study aims to generate multi-domain data to support predictive modelling and inform future personalised mental-health prevention strategies across childhood and young adulthood.",[91,92,93],"ADHD - Attention Deficit Disorder With Hyperactivity","Autism Spectrum Disorder (ASD)","Developmental Coordination Disorder (DCD)",[95,96,97],"Attention Deficit Disorder with Hyperactivity","Autism spectrum disorder","Developmental Coordination Disorder","2026-04-29",{"date":68,"type":36},{"date":101,"type":20},"2026-08-01",{"date":103,"type":20},"2028-12-31",{"name":42,"class":43},1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":84,"sex":53,"minAge":86,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":105},"100628115","function-and-lean-mass-preservation-with-resistance-exercise-during-a-glp-1ra-treatment-100628115","NCT07457437","Function and Lean Mass Preservation With Resistance Exercise During a GLP-1RA Treatment","Effect of a Progressive Resistance Exercise Program on Muscle Mass and Physical Function During a Tirzepatide Induced Weight Loss in Overweight and Obese Females: a Randomised Parallel Group Study","FLEX","Inclusion Criteria:\n\n* 25-50 years old\n* BMI ≥27 kg\u002Fm2 with one obesity related co-morbidity or a BMI between ≥30 and 35 kg\u002Fm2\n* Female\n\nExclusion Criteria:\n\n* Previous GLP-1RA use\n* Diabetes (Type 1 and 2)\n* Contraindicative health condition to GLP-1\u002FGIP\n* Fail clinically administered health screening form for tirzepatide prescription\n* Pregnant or wanting to become pregnant in the next 6 months\n* Has or has previously had an eating disorder\n* Inability to perform exercise program and exercise tests\n* Advised not to exercise by their general practitioner or medical professional\n* Current or recent injury within the last 6 months that may affect the ability to carry out resistance exercise\n* Has consistently resistance trained previously (\\>10 sessions per year)\n* Currently taking medication or supplements that have been shown to impact muscle function and muscle mass in the last 6 months\n* Current or recent, ≤6 months, smoker\n* Currently on HRT","50 Years",{"count":116,"type":20},60,[23],"This study aims to investigate the effect that a structured, progressive resistance exercise program may have on maintaining the muscle mass and physical function of overweight\u002F obese females whilst they experience a tirzepatide (GLP-1\u002FGIP receptor agonist) induced weight loss.\n\nOverweight and obese females aged 25-50 will be recruited for the study, they will require a BMI of \\>30 or \\>27 with one obesity related comorbidity (excluding diabetes). They will be screened, prescribed tirzepatide and then randomly assigned to either the intervention (GLP-1\u002FGIP + Exercise) or the control group (GLP-1\u002FGIP). Groups will then be split into pre and peri menopausal groups to provide a further exploratory pathway looking analysing if the menopause transition may have any effect on our outcome variables. This was proposed as in the UK females are more likely to begin GLP-1RA treatment.\n\nBoth groups will be given an industry standard treatment of tirzepatide over 20 weeks starting at a dose of 2.5mg\u002Fweek and following the dose titration process of +2.5mg\u002Fweek every four weeks outlined by its manufacturers. The Exercise Group (GLP-1 +EXC) will be given the same tirzepatide prescription alongside following a progressive resistance exercise program. The exercise program will follow a similar structure to previous work in which participants will complete a propriety 20-wk whole body, low impact resistance exercise training program four times a week. The exercise sessions will be up to an hour and will be instructor lead by video and supervised by a member of the research team at The University of Exeter.",[120,121,122],"Muscle Mass and Strength","Obesity & Overweight","Physical Function",[124,125,126,127,128],"Maintaining muscle mass on GLP-1RA, physical function on GLP-1RA, tirzepatide, Mounjaro,","Body composition changes during GLP-1\u002FGIP RA weight loss","Resistance exercise and Perimenopause","Lean mass and Tirzepatide","Health outcomes and obesity","RECRUITING","2026-03-23",{"date":132,"type":36},"2026-03-27",{"date":134,"type":20},"2026-04-01",{"date":136,"type":20},"2027-12-01",{"name":42,"class":43},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":105},"100448558","synaptic-loss-in-multiple-system-atrophy-100448558","NCT05121012","Synaptic Loss in Multiple System Atrophy","Molecular Imaging of Synaptic Loss in Multiple System Atrophy (MSA)","Inclusion Criteria\n\nMSA group:\n\nMale or female, aged 45-80 at the time of informed consent. Meet criteria for diagnosis of probable or possible MSA (Gilman et al., 2008) (Appendix 1).\n\nA female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b) of childbearing potential but not pregnant (as determined by urinary pregnancy test on screening and on each study day), is not lactating and is willing to use one of the contraception methods listed below:\n\n* Combined (estrogen and progesterone containing) hormonal contraception associated with initiation of ovulation( oral, intravaginal, or transdermal);\n* Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);\n* Intrauterine device;\n* Intrauterine hormone releasing system;\n* Bilateral tubal occlusion;\n* Vasectomized partner;\n* Sexual abstinence.\n\nMale subject with a female partner of child-bearing potential must use one of the following contraceptive methods for 90 days after each dose of radiotracer:\n\n* Condom plus partner use of a highly effective contraceptive (see point above) OR\n* Abstinence Subjects must understand the nature of the study and be able to provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. They must be able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.\n\nMust have anticipated survival of ≥3 years (in the opinion of the Investigator).\n\nMedical treatment of MSA and co-morbid medical conditions must be stable for at least 30 days prior to screening and between screening and baseline PET scan. Intermittently administered treatment may be considered stable if the dose and dosing frequency have been unchanged for the greater of 30 days or three dosing inbiomartervals (e.g. a treatment given once a month must be at a stable dose and dosing frequency for 3 months).\n\nFor inclusion in optional CSF sampling, written informed consent must be provided, either by separate signed and dated written informed consent or by specific written acknowledgement on the main study informed consent form, according to local procedure. Failure to participate in optional CSF sampling will have no influence on the subject's ability to participate in the main study.\n\nIn the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have high probability of completing the study.\n\nPSP Group:\n\nMale or female, aged 45-80 at the time of informed consent. Meet criteria for diagnosis of suggestive, probable or possible PSP - with preference for PSP-RS, PSP-OM, PSP-PI, PSP with gait freezing, and PSP-SL and PSP-P subtypes (Höglinger et al., 2017 (Appendix 2).\n\nA female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b) of childbearing potential but not pregnant (as determined by urinary pregnancy test on screening and on each study day), is not lactating and is willing to use one of the contraception methods listed below:\n\n* Combined (estrogen and progesterone containing) hormonal contraception associated with initiation of ovulation( oral, intravaginal, or transdermal);\n* Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);\n* Intrauterine device;\n* Intrauterine hormone releasing system;\n* Bilateral tubal occlusion;\n* Vasectomized partner; Sexual abstinence.\n\nMale subject with a female partner of child-bearing potential must use one of the following contraceptive methods for 90 days after each dose of radiotracer:\n\n• Condom plus partner use of a highly effective contraceptive (see point above) OR Abstinence Subjects must understand the nature of the study and be able to provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. They must be able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.\n\nExclusion criteria:\n\nMSA group:\n\nHistory of other neurological disorders or intracranial co-morbidities, such as stroke, haemorrhage, space-occupying lesions.\n\nPresence of supranuclear gaze palsy. Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgement of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results.\n\nSevere-to-complete dependence on caregivers (score \\>3 on UMSARS Part IV, Global Disability), severe impairment of swallowing (score ≥3 on UMSARS Part I, Question 2), or frequent falls (score ≥3 on UMSARS Part I, Question 8) at Screening.\n\nPresence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g. Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body. If the principal investigator considers the presence of any of the above not to be a contraindication to MRI in a given subject, the investigator may obtain approval from the MR operators based on a discussion of the case.Negative modified Allen test in both hands.\n\nHistory of claustrophobia or back pain that makes prolonged laying on the MRI or PET scanner intolerable.\n\nPregnancy, lactation, or, if female of childbearing potential, positive urine β-hCG at screening or prior to PET scan.\n\nUse of drugs acting on SV2A such as antiepileptics (e.g. levetiracetam or brivaracetam).\n\nHistory of brain surgery for parkinsonism or stem cell treatment. Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology.\n\nCurrent or recent history of alcohol or drug abuse \u002F dependence (except nicotine dependence).\n\nHistory of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin.\n\nHemoglobin A1c (HbA1c) ≥ 6.5% at screening. Uncontrolled\u002Fpoorly controlled diabetes mellitus.\n\nFor subjects participating in optional CSF sampling:\n\n* Any spinal malformation or other aspects (e.g. tattoos) \u002F clinical findings (e.g. papilledema) that may complicate or contraindicate lumbar puncture, as judged by the investigator.\n* Neoplasm or other space-occupying intracranial lesion on MRI. Any clinically important abnormality, as determined by the investigator, on physical examination or vital signs, ECG, or clinical laboratory test results other than abnormality due to a stable, well-controlled medical condition; or any abnormality that could be detrimental to the subject or could compromise the study.\n\nPSP group:\n\nHistory of other neurological disorders or intracranial co-morbidities, such as stroke, haemorrhage, space-occupying lesions.\n\nInclusion in any clinical trial with investigational drugs targeting tau. Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgement of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results.\n\nPresence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g. Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body. If the principal investigator considers the presence of any of the above not to be a contraindication to MRI in a given subject, the investigator may obtain approval from the MR operators based on a discussion of the case.\n\nAbnormal modified Allen test in both hands. History of claustrophobia or back pain that makes prolonged laying on the MRI or PET scanner intolerable.\n\nPregnancy, lactation, or, if female of childbearing potential, positive urine β-hCG at screening or prior to PET scan.\n\nHistory of brain surgery for parkinsonism or stem cell treatment. Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology.\n\nCurrent or recent history of alcohol or drug abuse \u002F dependence (except nicotine dependence).\n\nHistory of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin.\n\nFor subjects participating in optional CSF sampling:\n\n• Any spinal malformation or other aspects (e.g. tattoos) \u002F clinical findings (e.g. papilledema) that may complicate or contraindicate lumbar puncture, as judged by the investigator.\n\nNeoplasm or other space-occupying intracranial lesion on MRI. Any clinically important abnormality, as determined by the investigator, on physical examination or vital signs, ECG, or clinical laboratory test results other than abnormality due to a stable, well-controlled medical condition; or any abnormality that could be detrimental to the subject or could compromise the study.","45 Years","80 Years",{"count":148,"type":20},36,"In this study the investigators would like to investigate the degree of damage of the synapses, an important part of the neurons vital for the communications between neurons, in Multiple System Atrophy (MSA), and pathology related to abnormal accumulation of a protein named tau, in Progressive Supranuclear Palsy (PSP).",[151,152],"Multiple System Atrophy","Progressive Supranuclear Palsy (PSP)",[154,155,151,156,157],"Neurodegeneration","Positron Emission Tomography","Biomarkers","Progressive Supranuclear Palsy","2026-02-06",{"date":160,"type":36},"2026-02-10",{"date":162,"type":36},"2021-09-01",{"date":164,"type":20},"2027-03-31",{"name":42,"class":43},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":84,"sex":16,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":177,"conditions":178,"keywords":182,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":105},"100552825","understanding-beta-cell-disorders-through-the-study-of-rare-genotypes-endure-100552825","NCT06478121","Understanding Beta Cell Disorders Through the Study of Rare Genotypes (ENDURE)","ENDURE","Inclusion Criteria\n\n* Mental capacity to give informed consent\n* Of any sex, ethnicity, location.\n* Group 1: Cases will have a genetic variant(s) resulting in a beta cell disorder.\n* Group 2: Controls will not have a genetic variant(s) resulting in a beta cell disorder and will be matched to a Case for sex, age (+\u002F- 15%) and BMI (+\u002F- 3 kg\u002Fm2).\n\nExclusion Criteria\n\n* Lack of mental capacity to give informed consent\n* Age \\\u003C6 years; \\>99 years\n\nAdditional exclusions for MRI assessments:\n\n* Cochlear Implant\n* Aneurysm Clips\n* Neurological stimulator\n* Implanted cardiac devices (ICD, PPM, loop recorders, or any others)\n* Metal heart valve\n* History of metal foreign bodies in orbits\n* Other implanted metal device which prevents MRI\n* Known claustrophobia.","6 Years","99 Years",{"count":176,"type":20},50,"This observational 'recruit by genotype' study aims to provide insights into the cellular and molecular pathways underlying beta cell disorders and their physiological consequences. Eligible individuals are those with and without a pathogenic genetic variant, acting as case and control, respectively. Using a \"recruit by genotype\" approach, the researchers will perform detailed and specific analysis according to the individual's genetic variant.\n\nThe study's main aims are to : 1) identify and describe biomarkers and cellular features in blood samples that occur because of the rare causal genetic variant; 2) study the altered physiology or cellular function that are due to the rare causal genetic variant.\n\nParticipants will attend a study visit that will entail:\n\n* Consent\n* Data collection\n* Height and weight measures\n* Blood samples\n* MRI (optional), dependent on genotype and sub-study objectives.\n\nThere is no treatment and the participants' normal clinical care will be unaffected and will continue uninterrupted.\n\nA small subset of participants may be invited for further sub-studies in the future. Researchers may recruit sex-matched healthy controls (without the variant of interest) with similar age and BMI (age: +\u002F-15%, BMI: +\u002F- 3 kg\u002Fm2) for specified case-control studies.",[179,180,181],"Diabetes Mellitus","Monogenic Diabetes","Hyperinsulinism",[180,181,183,184,185,186],"Beta cell disorders","Genotype-to-phenotype","Causal genetic variant","Beta cell","2026-01-14",{"date":189,"type":36},"2026-01-16",{"date":191,"type":36},"2025-11-11",{"date":193,"type":20},"2029-02-28",{"name":42,"class":43},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100314156","extremely-early-onset-type-1-diabetes-extremely-early-onset-type-1-diabetes-a-musketeers-memorandum-study-100314156","NCT03369821","EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)","Understanding Beta-cell Destruction Through the Study of EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)","EXE-T1D","Inclusion Criteria:\n\nStudy 1:\n\nEET1D\n\n* Aged 0 to 70 years\n* Clinical diagnosis of diabetes \\\u003C24 months (+ evidence of WHO diabetes criteria)\n* Negative genetic test for mutations causing non-autoimmune neonatal diabetes if diagnosed \\\u003C12 months\n* Type 1 diabetes genetic risk score \\>50th centile of T1D reference group, or monogenic cause of T1D.\n\nT1D Controls\n\n* Age 0-70 years (matched to above)\n* Clinical diagnosis of T1D (diagnosed age 1-20 years)\n* Insulin treated from diagnosis.\n\nMonogenic \u002F NDM controls\n\n* Diagnosis of diabetes \\\u003C12 months\n* Diagnosis of monogenic \u002F NDM (confirmed by Exeter Molecular Genetics Laboratory).\n\nStudy 2:\n\nEET1D\n\n* Aged 0 to 24 months at recruitment\n* Clinical diagnosis of diabetes \\\u003C24 months (+ evidence of WHO diabetes criteria)\n* Negative genetic test for mutations causing non-autoimmune neonatal diabetes\n* Type 1 diabetes genetic risk score \\>50th centile of T1D reference group, or monogenic cause of T1D.\n\nMonogenic\u002FNDM controls\n\n* Diagnosis of diabetes \\\u003C24 months\n* Age 0 to 18 months at recruitment\n* Diagnosis of monogenic\u002FNDM (confirmed by Exeter Molecular Genetics Laboratory).\n\nNon-diabetic controls\n\n* Aged 0-6 years\n* Attending specified participating hospital sites for elective surgery, including but not limited to: inguinal hernia repair, umbilical\u002Fmidline hernia repair, orchidopexy, gastrostomy insertion\u002Fchange, hypospadias repair, cleft palate repair, excision of accessory digit, laryngoscopy, adenoidectomy, tonsillectomy, MRI under general anaesthesia, eye surgery.\n\nExclusion Criteria:\n\nStudy 1:\n\n* Aged \\>70 years\n* No diagnosis of diabetes\n* MODY (e.g. caused by HNF1A\u002FHNF4A\u002FHNF1B\u002FGCK mutations), type 2 diabetes or diabetes related to pancreatic insufficiency or syndromic diabetes\n* Intercurrent illness at time of sampling for PBMCs (see below).\n\nStudy 2:\n\n* Aged \\>24 months\n* Clinical diagnosis of diabetes \\>24 months\n* Intercurrent illness at time of sampling for PBMCs or RNA (see below).\n\nNon-diabetic controls:\n\n* Aged \\>6 years\n* Diagnosis of diabetes or other autoimmune condition\n* Known immunological disorder\n* On immunosuppressive medication\n* Ongoing infections\u002Fsepsis\n* Major congenital abnormality or significant systemic illness that may affect the immune system, e.g. metabolic disease, 22q deletion syndrome\n* Recent (within two weeks) febrile illness\n* Renal failure.\n\nFor PBMC and RNA sampling: Exclusion for factors that may alter T cell function and RNAseq\n\nReview the following exclusion criteria carefully at time of appointment as some details may have changed since initial contact:\n\n* Recreational drug use (excluding cannabis use more than 1 week prior to blood sampling) - drug abuse may alter T cell function\n* Alcohol related illness (excessive alcohol consumption may alter T cell function)\n* Renal failure: Creatinine \\>200 (as may alter T cell function)\n* Any other medical condition which, in the opinion of the investigator, would affect the safety of the subject's participation.\n\nFactors that if temporary would lead to rearrangement of study visit but if long duration, may lead to exclusion subject to the CI's discretion:\n\n* Pregnant or lactating (as this may limit blood sampling and affect T cell function)\n* Any infectious illness within the last 2 weeks if it was a febrile illness, or within 2-3 days if it was non-febrile (as this may activate T cells non-specifically)\n* Taking steroids or other immunosuppressive medications (as these may alter T cell function)\n* Received any immunoglobulin treatments or blood products in the last 3 months (as these may alter T cell function).","70 Years",{"count":205,"type":20},300,"Type 1 diabetes (T1D) results from destruction of insulin-producing beta cells in the pancreas by the body's own immune system (autoimmunity). It is not fully understood what causes this type of diabetes and why there is variation in age of onset and severity between people who develop the disease. The aim of this work is to study very unusual people who develop T1D extremely young, as babies under 2 years of age (EET1D). The investigators think that, for the condition to have developed that early, they must have an unusual or extreme form of autoimmunity.\n\nStudying people with EET1D will enable us to look at exactly what goes wrong with the immune system because they have one of the most extreme forms of the disease. Much may be learned about the disease from a small number of rare individuals. The investigators aim to confirm that they have autoimmune type 1 diabetes and then try to understand how they have developed diabetes so young by studying their immune system genes, the function of their immune system, and environmental factors (such as maternal genetics) that may play a role in their development of the disease.\n\nPeople with diabetes diagnosed under 12 months are very rare, live all over the world. and are usually referred to Exeter for genetic testing. Individuals will be contacted via their clinician to ask for more information about their diabetes and their family history. Samples will be collected to study whether they still make any of their own insulin and whether they make specific antibodies against their beta cells in the pancreas. Separately, their immune system will be studied in depth using immune cells isolated from a blood sample. These cells will undergo cutting edge techniques by Dr Tim Tree at King's College London, by Professor Bart Roep at Leiden University Medical Center, Netherlands, and Dr Cate Speake, Benaroya Research Institute, Seattle (USA). Some of these tests have never been used in people of young ages around the world, so an aim of this project will be to develop methods that can be used to study people even if they live far away.\n\nAdditional funding extended the study for a further 3 years (Phase 2) to include recruitment of infants without diabetes, aged 0-6 years, as controls to enable assessment of how the abnormalities found in autoimmune and non-autoimmune diabetes compare to normal early life development of the immune system.\n\nAn additional funding award extended the study (Phase 3) until November 2028, to advance the EXE-T1D program into its third phase, building on major discoveries from phases 1 and 2 to identify, validate, and target immune pathways that drive extremely early-onset type 1 diabetes (eeT1D) and are likely relevant to T1D across all ages. eeT1D cases, diagnosed within the first two years of life, represent particularly aggressive onset of beta-cell autoimmunity. They offer a unique lens to uncover mechanisms of immune dysregulation, informed by both polygenic and monogenic causes. The central aim is to move from pathway discovery to demonstration of novel druggable targets with potential to delay or prevent T1D onset across all ages.",[208],"Type1 Diabetes Mellitus",[210,211,212,213,214,215,216,217],"type 1 diabetes","monogenic diabetes","autoimmune diabetes","early-onset autoimmune diabetes","beta cell (β-cell) destruction","type 1 diabetes genetic risk","extremely early-onset Type 1 diabetes","neonatal diabetes","2025-12-12",{"date":220,"type":36},"2025-12-19",{"date":222,"type":36},"2017-09-19",{"date":224,"type":20},"2028-11-30",{"name":42,"class":43},4,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":146,"enrollmentInfo":235,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":105},"100479102","molecular-and-functional-imaging-in-monogenic-pd-100479102","NCT05518617","Molecular and Functional Imaging in Monogenic PD.","Molecular and Functional Imaging of Parkinson's Pathology in SNCA, Parkin and PINK1 Mutation Carriers","FOX_1","Inclusion Criteria:\n\n* All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.\n* All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.\n* All subjects must be able to travel to the research sites for the study procedures.\n* For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.\n* All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:\n\nOral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;\n\nOral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:\n\nIntrauterine device (IUD)\n\nIntrauterine hormone-releasing system (IUS)\n\nBilateral tubal occlusion\n\nVasectomised partner\n\nSexual abstinence\n\n* For sexually active male subjects, they must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. They must also agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands.\n\n  \\*\\*All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.\n* All subjects must have no use of medications with known interaction with serotonergic transmission (e.g. selective serotonin reuptake inhibitors, tricyclic antidepressant, triptans, etc).\n* For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.\n\nExclusion Criteria:\n\n* Subjects lacking capacity according to investigator judgement.\n* Subjects with a clinical diagnosis of dementia as determined by the investigator.\n* Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude safe completion of the lumbar puncture.\n* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.\n* Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).\n* History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.\n* Subjects with current or recent history of drug or alcohol abuse\u002Fdependence.\n* Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable.\n* Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n* Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.",{"count":236,"type":20},45,"In this study, the investigators aim to find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of PD symptoms.",[239,240,241,242,243],"Parkinson Disease","Nervous System Disorder","Neurodegenerative Diseases","Neurodegenerative Disease, Hereditary","Parkinson's","2025-10-01",{"date":246,"type":36},"2025-10-07",{"date":248,"type":36},"2022-07-01",{"date":250,"type":20},"2026-06-30",{"name":42,"class":43},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":268,"leadSponsor":269,"locationsCount":105},"100478957","serotonin-release-in-premotor-and-motor-pd-100478957","NCT05516732","Serotonin Release in Premotor and Motor PD","Evaluation of Serotonergic Neurotransmission in Premotor and Motor Parkinson's Disease.","FOX3","Inclusion criteria-\n\n* Subjects must understand the nature of the study and must provide signed and dated written HRA-approved informed consent in accordance with local regulations before any protocol-specific screening procedures are performed;\n* Males and females, age 25-85 years, inclusive;\n* Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative β-hCG test at screening. For sexually active subjects (except females of non-childbearing potential-e.g., at least 2 years postmenopausal or surgically sterile), condoms should be used in addition to other birth control methods for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. These patients must be willing to remain on their current form of contraception for the duration of the study. All male subjects must agree to refrain from donating sperm for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. Sexually active male subjects must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands (i.e. for 15 consecutive months following baseline PET and SPECT scans); agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands;\n* Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures;\n* Adequate visual and auditory acuity to complete the psychological testing;\n* In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.\n\nExclusion criteria -\n\n* Subjects lacking capacity according to investigator judgement;\n* Subjects taking serotonin acting drugs such as antidepressants (i.e. tricyclic or selective serotonin reuptake inhibitors etc.);\n* Pregnancy or breastfeeding or intent to become pregnant in the next 18 months;\n* Subjects with current or a recent history of drug or alcohol abuse\u002Fdependence;\n* Subjects who have other neurological disorders and known intracranial co-morbidities such as stroke, hemorrhage, space-occupying lesions;\n* Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results;\n* History of suicidal behaviour or active suicidal ideation;\n* Within 1 year prior to screen or between screen and baseline (Day -1), any of the following: myocardial infarction; hospitalization for congestive heart failure; hospitalization for, or symptoms of, unstable angina; or syncope not related to PD;\n* History or presence of renal disease or impaired renal function;\n* Clinically important infection (e.g., chronic, persistent, or acute infection) within 30 days prior to screen or between screen and baseline (Day -1);\n* History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin;\n* Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology;\n* Use of antipsychotic medication within 3 months prior to screen or between screen and baseline (Day -1);\n* Use of any anticoagulant within 30 days prior to baseline and follow-up PET scans;\n* Use of any oral corticosteroid within 30 days prior to baseline and follow-up PET scans;\n* Use of metoclopramide within 30 days prior to baseline and follow-up (Day -1);\n* Use of any thyroid medication within 30 days prior to baseline and follow-up (Day -1);\n* Regular use (e.g., taken \\> 3 days\u002Fweek) of narcotic pain medications within 30 days prior to baseline and follow-up (Day -1);\n* Presence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g., Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body;\n* Negative modified Allen test in both hands, unless the brachial artery is used for arterial cannulation;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable;\n* History of severe skin allergy;\n* Patients who had previous surgery for PD (including but not limited to deep brain stimulation \\[DBS\\] or cell transplantation);\n* Patients who are treated with duodopa or apomorphine;\n* Initiation or change in pharmacologic therapy for symptoms of PD within 30 days prior to screen or between screen and baseline and follow-up (Day -1).\n* GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study).\n* STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study.","85 Years",{"count":262,"type":20},42,"In this study, the investigators aim to provide a deeper understanding of Parkinson's disease and find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of Parkinson's disease symptoms",[239,243,265,241,154,155],"Parkinson's Disease",{"date":246,"type":36},{"date":248,"type":36},{"date":250,"type":20},{"name":42,"class":43},{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":84,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":286,"locationsCount":105},"100478956","longitudinal-investigation-of-i2bs-in-pd-100478956","NCT05516719","Longitudinal Investigation of I2BS in PD","Longitudinal Investigation of Imidazoline-2 Binding Site as a Novel Marker of Disease Progression in Parkinson's Disease: An [11C]BU99008 PET Study","FOX_2","Inclusion criteria\n\n* All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.\n* All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.\n* All subjects must be able to travel to the research sites for the study procedures.\n* Age 25 years or older.\n* For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.\n* All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:\n\nOral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;\n\nOral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:\n\nIntrauterine device (IUD)\n\nIntrauterine hormone-releasing system (IUS)\n\nBilateral tubal occlusion\n\nVasectomised partner\n\nSexual abstinence\n\n* For sexually active male subjects, they must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. They must also agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands.\n* All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.\n* All subjects must have no use of medications with known interaction with I2BS (e.g. idaxozan, efaroxan, yohimbine, atomoxetine, atipamezole, mianserin, mirtazapine, clonidine, guanfacine, guanabenz, guanethidine, xylazine, tizanidine, tedetomidine, methyldopa, fadolmidine, dexmedetomidine)\n* For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.\n\nExclusion criteria\n\n* Subjects lacking capacity according to investigator's judgment;\n* Subjects with a clinical diagnosis of dementia as determined by the investigator;\n* Subjects with current or a recent history of drug or alcohol abuse\u002Fdependence;\n* Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude the arterial cannulation and the safe completion of the lumbar puncture.\n* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n* Negative Allen test in both hands,\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.\n* Use of any medications with known actions on I2BS (e.g. idaxozan, efaroxan, yohimbine, atomoxetine, atipamezole, mianserin, mirtazapine, clonidine, guanfacine, guanabenz, guanethidine, xylazine, tizanidine, tedetomidine, methyldopa, fadolmidine, dexmedetomidine);\n* Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).\n* History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.\n* Subjects with current or recent history of drug or alcohol abuse\u002Fdependence.\n* Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET, SPECT, or MRI scanner intolerable.\n* Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n* Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results;\n* History of suicidal behavior or active suicidal ideation;\n* Pregnancy or breastfeeding or intent to become pregnant in the next 18 months;",{"count":279,"type":20},44,"In this study, the researchers aim to find a biomarker of PD. Using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The PET and SPECT scans use small amounts of radiation and specific compounds called tracers, to study chemical changes in the brain in a way not possible with any other procedure. The MRI uses magnetic fields to generate images of brain structure and function",[243,239,265,241,154,155],{"date":246,"type":36},{"date":284,"type":36},"2021-11-01",{"date":250,"type":20},{"name":42,"class":43},{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":84,"sex":16,"minAge":114,"maxAge":260,"enrollmentInfo":294,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":105},"100455034","molecular-imaging-of-inflammation-in-parkinsons-disease-using-lps-and-tspo-petmr-100455034","NCT05205291","Molecular Imaging of Inflammation in Parkinson's Disease Using LPS and TSPO-PET\u002FMR","Molecular Imaging of LPS-induced Microglial Activation in Parkinson's Disease (PD). A TSPO PET-MR Imaging Study","Inclusion Criteria (all):\n\n* 50-85 years of age, male or female\n* Able to give informed consent\n* Adequate visual and auditory acuity to complete the neuropsychological testing\n* No presence or history of significant neurological or psychiatric disorders\n* BDI ≥ 20, moderate depression\n* No presence or history of inflammatory or autoimmune disorders\n* Negative family history for neurodegenerative diseases\n* Cognitively healthy (i.e., education-adjusted MoCA total score ≥ 26 points at screening)\n* Female subjects must either be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause) or if they are of childbearing potential, they must commit to use of a highly effective contraceptive measure for the duration of the study and a minimum of six months following the PET scan (including combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).\n* Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception during the study and for a minimum of three months following each PET scan (including, for female partners of childbearing potential, combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).\n* Male subjects must commit to not donate sperm during the study and for a minimum of three months after the last PET scan.\n* Individuals must commit to refrain from drinking alcohol for 48 hours before each visit, refrain from drinking any caffeinated substance for 12 hours before the PET-MR visits, and to refrain from smoking or using any nicotine-containing products on the day of the PET-MR scans.\n* Individuals must commit to not donating blood up to three months after the last PET scan.\n* Individuals must commit to come to the screening and Day 1 visits in a fasting state (i.e., minimum of 8 hours since last meal\u002Ffood intake).\n* Individuals must commit to not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48h before screening visit.\n\nInclusion Criteria (Parkinson's disease patients):\n\n* 50-85 years of age, male or female\n* Able to give informed consent\n* Adequate visual and auditory acuity to complete the neuropsychological testing\n* No presence or history of other significant neurological or psychiatric disorders\n* Diagnosis of PD according to the Movement Disorder Society Clinical Diagnostic Criteria (Postuma et al., Mov Disord 2015)\n* Drug-naïve participants with PD must have a diagnosis of PD but must be therapy-free at the time of enrolment\n* For participants with PD-MCI: diagnosis of MCI according the diagnostic criteria for MCI-PD (Level I; Litvan et al., Mov Disord 2012) and\u002For MoCA \\\u003C 23\n* For participants with PD taking dopaminergic therapy: must be in stable therapy (i.e. not have changed therapy in the last 60 days)\n* Female subjects must either be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause) or if they are of childbearing potential, they must commit to use of a highly effective contraceptive measure for the duration of the study and a minimum of six months following the PET scan (including combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).\n* Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception during the study and for a minimum of three months following each PET scan (including, for female partners of childbearing potential, combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).\n* Male subjects must commit to not donate sperm during the study and for a minimum of three months after the last PET scan.\n* Individuals must commit to refrain from drinking alcohol for 48 hours before each visit, refrain from drinking any caffeinated substance for 12 hours before the PET-MR visits, and to refrain from smoking or using any nicotine-containing products on the day of the PET-MR scans.\n* Individuals must commit to not donating blood up to three months after the last PET scan.\n* Individuals must commit to come to the screening and Day 1 visits in a fasting state (i.e., minimum of 8 hours since last meal\u002Ffood intake).\n* Individuals must commit to not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48h before screening visit.\n\nFor participants with iRBD:\n\nInclusion criteria:\n\n* 40-85 years of age, male or female\n* Able to give informed consent\n* Adequate visual and auditory acuity to complete the neuropsychological testing\n* No presence or history of significant neurological or psychiatric disorders\n* BDI-II ≥ 20, moderate depression\n* No presence or history of inflammatory or autoimmune disorders\n* Negative family history for neurodegenerative diseases\n* Cognitively healthy (i.e., education-adjusted MoCA total score ≥ 26 points at screening)\n* Female subjects must either be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause) or if they are of childbearing potential, they must commit to use of a highly effective contraceptive measure for the duration of the study and a minimum of six months following the PET scan (including combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).\n* Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception during the study and for a minimum of three months following each PET scan (including, for female partners of childbearing potential, combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).\n* Male subjects must commit to not donate sperm during the study and for a minimum of three months after the last PET scan.\n* Individuals must commit to refrain from drinking alcohol for 48 hours before each visit, refrain from drinking any caffeinated substance for 12 hours before the PET-MR visits, and to refrain from smoking or using any nicotine-containing products on the day of the PET-MR scans.\n* Individuals must commit to not donating blood up to three months after the last PET scan.\n* Individuals must commit to come to the screening and Day 1 visits in a fasting state (i.e., minimum of 8 hours since last meal\u002Ffood intake).\n* Individuals must commit to not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48h before screening visit.\n\nExclusion Criteria (all):\n\n* Unwilling and\u002For unable to cooperate with study procedures\n* Current or a recent (\\\u003C12 months) history of drug or alcohol abuse\u002Fdependence\n* BDI ≥ 20, moderate depression\n* Presence of clinically significant (as deemed by the study physician) alterations on safety laboratory blood and urine testing\n* Presence of comorbidities or concomitant medications incompatible with the assessment or imaging procedures as deemed by the study physician\n* Recent (less than 30 days) use of antipsychotics and corticosteroids\n* Recent (less than 2 days) use of NSAIDs.\n* Use of any long-acting benzodiazepines (e.g., diazepam) or use of slow or medium acting benzodiazepines with doses ≥ 30 mg within 30 days prior to the first imaging scan.\n* Presence of rs6971 genotype of low-affinity binders that hinders the measure of microglial activation with \\[11C\\]PBR28 PET\n* Presence of neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions, signs of inflammation of the CNS\n* Presence of serology compatible with HIV, syphilis, SARS-CoV2, or viral hepatitis\n* History of autonomic dysfunction, previous vasovagal syncope or a positive tilt-test, and with bradycardia or use of medications causing bradycardia (e.g. beta-blockers)\n* Pregnancy or breastfeeding\n* Contraindication to MRI, such as presence of metal devises or implants, metal deposited in the body, or metal grains in the eyes\n* History of cancer within the last 5 years, except for appropriately treated, non-melanoma skin carcinoma, non-metastatic prostate cancer, treated carcinoma in situ of the cervix or Stage I uterine cancer.\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable\n* Contraindication to arterial cannulation, such as history of bleedings, haemorrhage, etc.\n* Negative Allen's test (i.e. absence of collateral flow on hands on the test)\n* Recent (less than 30 days) infection or vaccination (e.g. flu, SARS-CoV2 etc.)\n* Concurrent participation to any clinical trial testing investigational drugs\n\nExclusion Criteria (Parkinson's disease patients):\n\n* Unwilling and\u002For unable to cooperate with study procedures\n* Current or recent history of drug or alcohol abuse\u002Fdependence\n* BDI ≥ 20, moderate depression\n* Presence of clinically significant (as deemed by the study physician) alterations on safety laboratory blood or urine testing\n* Presence of comorbidities or concomitant medications incompatible with the assessment or imaging procedures as deemed by the study physician\n* Recent (less than 30 days) use of antipsychotics and corticosteroids.\n* Recent (less than 2 days) use of NSAIDs.\n* Use of any long-acting benzodiazepines (e.g., diazepam) or use of slow or medium acting benzodiazepines with doses ≥ 30 mg within 30 days prior to the first imaging scan.\n* Presence of rs6971 genotype of low-affinity binders that hinders the measure of microglial activation with \\[11C\\]PBR28 PET\n* Presence of other neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions, signs of inflammation of the CNS\n* History of autonomic dysfunction, previous vasovagal syncope or a positive tilt-test, and with bradycardia or use of medications causing bradycardia (e.g. beta-blockers)\n* Presence of serology compatible with HIV, syphilis, SARS-CoV2, or viral hepatitis\n* Pregnancy or breastfeeding\n* Contraindication to MRI, such as presence of metal devises or implants, metal deposited in the body, or metal grains in the eyes\n* History of cancer within the last 5 years, except for appropriately treated, non-melanoma skin carcinoma, non-metastatic prostate cancer, treated carcinoma in situ of the cervix or Stage I uterine cancer.\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable\n* Contraindication to arterial cannulation, such as history of bleedings, haemorrhage, etc.\n* Negative Allen's test (i.e. absence of collateral flow on hands on the test)\n* Recent (less than 30 days) infection or vaccination (e.g. flu, SARS-CoV2 etc.)\n* Concurrent participation to any clinical trial testing investigational drugs\n\nExclusion criteria (for participants with iRBD):\n\n* Unwilling and\u002For unable to cooperate with study procedures\n* Current or a recent (\\\u003C12 months) history of drug or alcohol abuse\u002Fdependence\n* BDI-II ≥ 20, moderate depression\n* Presence of clinically significant (as deemed by the study physician) alterations on safety laboratory blood and urine testing\n* Presence of comorbidities or concomitant medications incompatible with the assessment or imaging procedures as deemed by the study physician\n* Recent (less than 30 days) use of antipsychotics and corticosteroids\n* Recent (less than 2 days) use of NSAIDs.\n* Use of any long-acting benzodiazepines (e.g., diazepam) or use of slow or medium acting benzodiazepines with doses ≥ 30 mg within 30 days prior to the first imaging scan.\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: Ephedrine, ketamine, isoflurane, cocaine, methylphenidate, amphetamine of any amphetamine derivatives, mazindol, modafinil, benztropine, fentanyl, derivatives, buproprion, phentermine neuroleptics, metoclopramide, alpha methyldopa, , reserpine, .\n* Presence of rs6971 genotype of low-affinity binders that hinders the measure of microglial activation with \\[11C\\]PBR28 PET\n* Presence of neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions, signs of inflammation of the CNS\n* Presence of serology compatible with HIV, syphilis, or viral hepatitis\n* History of autonomic dysfunction, previous vasovagal syncope or a positive tilt-test, and with bradycardia or use of medications causing bradycardia (e.g. beta-blockers)\n* Pregnancy or breastfeeding\n* Contraindication to MRI, such as presence of metal devises or implants, metal deposited in the body, or metal grains in the eyes\n* History of cancer within the last 5 years, except for appropriately treated, non-melanoma skin carcinoma, non-metastatic prostate cancer, treated carcinoma in situ of the cervix or Stage I uterine cancer.\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable\n* Contraindication to arterial cannulation, such as history of bleedings, haemorrhage, etc.\n* Negative Allen's test (i.e. absence of collateral flow on hands on the test)\n* Recent (less than 30 days) infection or vaccination (e.g. flu, SARS-CoV2 etc.)\n* Evidence of presynaptic dopaminergic denervation on \\[123I\\]FP-CIT SPECT\n* Concurrent participation to any clinical trial testing investigational drugs",{"count":295,"type":20},30,"It is not known what causes Parkinson's disease and what makes it worsen over time. Research conducted in the past few years has highlighted the possible role of inflammation on this process but its actual mechanisms are still obscure.\n\nIn this study, the investigators aim to gain understanding on how inflammation is increased in Parkinson's disease and what are its mechanisms, by performing two Positron Emission Tomography (PET) scans using the tracer \\[11C\\]PBR28, that takes pictures of the brain highlighting the areas of inflammation, before and after the administration of a compound called Lipopolysaccharide or LPS, that is known to cause a mild degree of inflammation. The investigators will couple this study with two venous blood draws to measure the levels of circulating molecules of inflammation.",[241,239,298],"REM Sleep Behavior Disorder (iRBD)",[155,300,301,156],"Inflammation","Neuroimaging",{"date":246,"type":36},{"date":304,"type":36},"2022-02-28",{"date":306,"type":20},"2026-08-31",{"name":42,"class":43},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":84,"sex":16,"minAge":316,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":323,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":105},"100590306","the-effect-of-a-plant-based-protein-dense-sauce-on-essential-amino-acid-concentrations-and-gut-fullness-in-older-adults-100590306","NCT06965699","The Effect of a Plant-based, Protein-dense Sauce on Essential Amino Acid Concentrations and Gut Fullness in Older Adults","Testing the Effect of a Plant-based, Protein-dense Sauce (ProSauce) on Metabolic Availability of Essential Amino Acids and Gut Fullness and Satiety in Older Adults","ProSauce","Inclusion Criteria:\n\n* Aged 60 and over\n* Living independently in the community\n* Capacity to provide informed consent\n* Non-smoking (vaping is considered smoking)\n* No known medical conditions that might influence the study outcomes, e.g., heart disease, diabetes mellitus, obesity, disthyroidism and other endocrinopathies and renal failure\n* Not taking any medications that might influence the study outcomes e.g., taking anabolic steroids or corticosteroids long term\n* No clinically diagnosed eating disorders\n* No severe dislike or allergy to any of the study food\n* No hospitalisations in the last 6 months\n* Not dieting and weight stable for 3 months before the study (\\\u003C 3 kg change in weight)\n\nExclusion Criteria:\n\n* Age \\\u003C 60y\n* Smoking\n* Food allergies\n* Cognitive and mobility issues\n* Hospitalisation in the last 6 months\n* Known medical conditions that might influence the study outcomes\n* Taking medications that influence the study outcomes","60 Years",{"count":5,"type":20},[23],"The goal of this clinical trial is to determine whether meals fortified with plant-based high protein sauce (ProSauce) provide better metabolic availability of essential amino acids compared to meals with standard lower-protein sauce without resulting in excessive gut fullness and satiety. The main questions it aims to answer are:\n\nDoes meals with high-protein sauce deliver better metabolic availability of amino acid profile? Does this high-protein sauce also not lead to excessive appetite suppression due to its liquid form? Researchers will compare high protein sauce to a commercially available standard low protein sauce.\n\nParticipants will consume two meals, either protein-fortified or standard low-protein sauce, in a randomised order with at least a one-week washout period between each meal. The investigators will collect venous blood samples over a 6-hour postprandial period to measure plasma essential (and non-essential) amino acid and insulin concentrations. The investigators will also measure appetite-related hormones from venous plasma and assess subjective appetite using a visual analogue scale, taken in parallel with the blood sample time points.",[321,322],"Malnutrition Elderly","Protein Malnutrition",[324,325,326,327],"plant-based protein sauce","older adults","amino acid metabolic availability","appetite regulation","2025-09-17",{"date":330,"type":36},"2025-09-23",{"date":332,"type":36},"2025-07-10",{"date":334,"type":20},"2026-04-30",{"name":42,"class":43},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":21,"phases":345,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":105},"100599270","the-effect-of-ketone-monoesters-on-skeletal-muscle-protein-synthesis-and-whole-body-protein-metabolism-100599270","NCT07082309","The Effect of Ketone Monoesters on Skeletal Muscle Protein Synthesis and Whole-body Protein Metabolism.","WAKM","Inclusion Criteria:\n\n• BMI 18-30\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\\u003C 18.5 or \\> 30 kg\u002Fm2\n* Age \\\u003C 18 or \\> 40\n* Regularly smokes\n* Type 2 diabetes\n* Cardiovascular disease, metabolic disease and hypertension (≥ 140\u002F90 mmHg)\n* Gastrointestinal disorders\n* Use medicines that may impact protein metabolism or that are anti-inflammatory (determined at the screening)\n* Pregnancy","40 Years",{"count":19,"type":20},[23],"The ketone β-hydroxybutyrate (BHB) is endogenously produced during periods of low glucose availability, serving as an alternative metabolic fuel. Beyond its role as an energy substrate, BHB acts as a pleiotropic signalling molecule, modulating various physiological processes across multiple tissues. BHB can also be ingested orally as a ketone monoester, transiently elevating plasma concentrations of BHB to a level similar to those seen following several days of fasting, thereby obviating the need for dietary manipulation. The influence of BHB on human skeletal muscle protein metabolism remains poorly understood, although emerging evidence suggests that BHB may play a role in regulating muscle protein turnover. As such, BHB supplementation may support skeletal muscle remodelling and offer therapeutic benefits, and investigating this is of considerable interest. This study will investigate the ability of oral BHB ingestion - co-ingested with protein - to stimulate skeletal muscle anabolism in young healthy adults. A dual amino acid stable isotope tracer approach will be utilised to determine postprandial (i.e., fed state) muscle protein synthesis (MPS) rates and whole-body amino acid kinetics, given BHBs systemic effects. This research will advance our understanding of the fundamental biology of exogenous ketosis and provide insight into the potential of BHB supplementation as a novel nutritional strategy to optimise muscle mass and quality.",[348],"Healthy Participants",[350,351,352],"ketone monoesters","muscle protein synthesis","amino acid metabolism","2025-07-15",{"date":355,"type":36},"2025-07-24",{"date":357,"type":36},"2025-06-04",{"date":359,"type":20},"2027-07",{"name":42,"class":43},{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":4},"100588398","development-of-a-novel-screening-tool-for-anosognosia-after-stroke-100588398","NCT06940882","Development of a Novel Screening Tool for Anosognosia After Stroke.","Development and Exploration of the Acceptability and Feasibility of a Novel Screening Tool for Anosognosia After Stroke, Designed for Routine Use in Hospital Settings.","Inclusion Criteria:\n\n* Patients aged 18 years or above who are admitted to the stroke rehabilitation unit with a clinical diagnosis of stroke.\n* Multi-disciplinary staff working on the stroke rehabilitation unit.\n\nExclusion Criteria:\n\n* Patients with a clinical diagnosis other than stroke.",{"count":369,"type":20},90,"Anosognosia, a neurological inability to acknowledge or comprehend one's own (dis)abilities, is a multi-faceted phenomenon which has consistently gained traction in research fields spanning psychology, neurology, and cognition since its conceptual introduction in 1914. Though anosognosia is not limited to following only neurological disease or injury, the majority of research has focused on the prevalence and mechanisms of anosognosia after stroke. Despite this, there is no clear consensus among the literature, and thus in clinical practice, as to how anosognosia after stroke should be assessed. This is startling given the plethora of studies which highlight anosognosia as a barrier to rehabilitation, a risk to safe discharge, and a predictor of poorer psychological and functional outcomes for both patients and their carers. Currently, there exists a vast number of assessment methods for anosognosia after stroke, which vary from performance- and observation-based tasks to self-report and discrepancy-based interviews; clinicians working in stroke make arbitrary choices as to which of these methods to use on a case-by-case basis, risking missed cases and subsequently noncomprehensive care. This research aims to develop a new screening tool for anosognosia that can be routinely implemented with post-stroke patients in hospital settings, to inform care, rehabilitation, and discharge. The study will explore the acceptability and feasibility of the new screening tool among multi-disciplinary staff working on a stroke rehabilitation unit, and provide grounds for future studies to assess the screen's psychometric properties and ability to inform novel interventions for anosognosia. Findings will have great implications for stroke survivors, their carers, and healthcare professionals alike.",[372,26],"Anosognosia",[372,26,374],"Assessment","2025-04-23",{"date":377,"type":36},"2025-04-27",{"date":379,"type":20},"2025-10",{"date":381,"type":20},"2026-06",{"name":42,"class":43},{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":390,"targetDuration":391,"studyType":56,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":105},"100582464","short-term-effect-of-using-non-immersive-gamified-exercises-on-chronic-pain-in-people-with-stroke-100582464","NCT06863649","Short-term Effect of Using Non-immersive Gamified Exercises on Chronic Pain in People With Stroke.","Measuring Biomarkers for Health in Community Environments: eMBraCE Activity Program; Short Term Effect of Using Non-immersive Gamified Exercises on Chronic Shoulder Pain in People With Chronic Stroke.","Inclusion Criteria:\n\n* Experiencing motor difficulties in using the paretic arm, with some use of hand\u002Farm as determined by therapist\n* Not participating any other intervention studies\n* Male\u002Ffemale ≥18 years old\n* Had a stroke requiring with any degree of arm mobility.\n* Capacity to consent to participate\n* Able to communicate adequately in English with the research team\n* Mild or moderate pain in shoulder or upper limb (below 6 and more than 2on the VAS scale).\n* Able to walk without any assistant at least for ten meters\n\nExclusion Criteria:\n\n* Any medical condition compromising the safety or the ability to take part to the study as determined by the therapist (such as insufficient vision or hearing, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)\n* History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure\n* Unable to follow two stage command\n* Moderate to severe hemi-spatial neglect compromising the ability to take part to the study, as determined by rehab team\n* Severe spasticity (more than 2 on the modified Ashworth scale)\n* Any device preventing use of EMG, FNIRS i.e. DBS or pacemaker",{"count":295,"type":20},"1 Day","Rehabilitation after stroke is essential to minimize permanent disability. Gamification of exercises has emerged as a promising strategy for increasing motivation and rehabilitation efficacy in people with stroke. However, there is a gap in understanding how exercise gamification can aid in pain management among people with stroke who are experiencing shoulder pain difficulties.\n\nThis study aims to evaluate the short-term effect of using gamified non-immersive exercises on shoulder pain level, upper limb range of motion, and shoulder and elbow muscle activities while doing different activities in people with chronic stroke. The study will be conducted using an observational study design. Various lab assessments include measuring the ROM of the shoulder (MOCAP), EMG, FNIRS, pain intensity using VAS scale, and muscles activities patterns across upper limb joints.",[394],"Stroke Patients","2025-04-15",{"date":397,"type":36},"2025-04-16",{"date":399,"type":36},"2025-03-01",{"date":401,"type":20},"2025-09",{"name":42,"class":43},{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":84,"sex":16,"minAge":411,"maxAge":146,"enrollmentInfo":412,"targetDuration":4,"studyType":21,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":105},"100581610","the-effect-of-ingesting-a-novel-algae-protein-source-on-rested-and-exercised-muscle-protein-synthesis-rates-in-older-adults-100581610","NCT06852547","The Effect of Ingesting a Novel Algae Protein Source on Rested and Exercised Muscle Protein Synthesis Rates in Older Adults.","Ingestion of a Novel Algae Protein Source on Rested and Post Exercise Muscle Protein Synthesis Rates.","CALM","Inclusion Criteria:\n\nMales and Females BMI 18.5 - 30 kg\u002Fm2 Aged 65-80 years Recreationally Active\n\nExclusion Criteria:\n\nBody mass index (BMI) \\\u003C18.5 or \\>30 kg\u002Fm2 Any metabolic impairments Any cardiovascular impairments High blood pressure (≥140\u002F90 mmHg) Any gastrointestinal disorders Any medications known to affect protein and\u002For amino acid metabolism A personal or family history of epilepsy, seizures or schizophrenia, motor disorder Chronic over the counter use of pharmaceuticals (\\> 1 month) Allergic to any of the whole foods included in the study","65 Years",{"count":413,"type":20},15,[23],"To assess the rested and postexercise muscle protein synthetic response following the ingestion of a flavourless algae protein source compared with whey protein in older adults.",[417],"Nutritional Intervention",[419,420,325,421],"novel protein","protein synthesis","alge","2025-02-24",{"date":424,"type":36},"2025-02-28",{"date":426,"type":36},"2025-02-23",{"date":428,"type":20},"2026-03-01",{"name":42,"class":43},{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":438,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":441,"briefSummary":442,"conditions":443,"keywords":447,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":44},"100581129","obesity-prevention-in-children-and-young-people-treated-for-acute-lymphoblastic-leukaemia-with-alltogether-100581129","NCT06846294","Obesity Prevention in Children and Young People Treated for Acute Lymphoblastic Leukaemia with ALLTogether","OBesity PREVention in Children and Young People Treated with ALLtogetheR: Prehabilitation Feasibility Intervention","BREVARY","Inclusion Criteria:\n\n* CYP aged between 5 - 21 years.\n* Newly diagnosed or relapsed CYP\\_ALL treated in University Hospital Bristol and Weston NHS Foundation Trust and Hospital Infantil Universitario Nino Jesus, Madrid\n* Within two weeks of being recruited to ALLTogether.\n* Treated with curative intent.\n\nExclusion Criteria:\n\n* CYP not partaking in ALLTogether.\n* CYP treated with palliative intent.\n* Those excluded by healthcare professionals or clinical reasons","5 Years","21 Years",{"count":369,"type":20},[23],"Background Leukaemia is the most common cancer in children with 800 diagnoses per year in England. To survive, children need strong treatments like chemotherapy and steroids given usually through clinical trials. The current trial used by the NHS is called ALLTogether. Fifty percent of children become obese during treatment due to increased hunger, cravings for junk foods and lack of physical activity. Obesity raises the chance of cancer relapse by 31%, makes treatment side-effects worse and makes it harder to kill off leukaemia cells, which affects how well children do during treatment, as indicated by minimal residual disease, a key predictor of prognosis.\n\nAims and Objectives This study (called BREVARY) aims to see if we can successfully provide personalised diet and physical activity with behaviour support for children and young people with leukaemia who are being treated with the ALLTogether trial. It will help us figure out if we can perform a bigger study, if this programme could reduce obesity and side-effects and improve survival and wellbeing.\n\nHow it will be done We plan to randomly assign participants to one of three groups; one group will get both a diet and physical activity plan, another will get only a diet plan, and the last group will receive standard care. This will take place in Hospital Infantil Universitario Nino Jesus, Madrid and Bristol Royal Hospital for Children and Southwest England NHS-sites. The diet and exercise plans will be created in partnership with the children and their families and delivered online or during regular hospital visits. The diet will follow healthy eating guidelines, consider personal food preferences (including cultural and religious needs), treatment side-effects and personal finances. Assessments of fitness and strength will be taken to plan personalised activities. During the study, the following data will also be collected: weight, height, body fat, diet, biomarkers, microbiome, muscle strength and wellbeing at three different times. \"One to one\" interviews will be conducted at the end to obtain feedback on their experiences with BREVARY.\n\nThis study aims to find out if children and their families\u002Fcarers are willing to participate in BREVARY, if enough people sign up and stay until the end and if our interventions and health measurements are appropriate.\n\nPotential Impact The results will help determine if a larger study can be performed, if changes are needed and what the cost will be. The study will be disseminated through networks, targeting underserved communities, healthcare professionals and affected families using accessible platforms to spread the word.",[444,445,446],"Diet Intervention","Physical Activity Intervention","Standard Care Control",[448,62,449,450,451,452],"Diet","Obesity","Acute Lymphoblastic Leukaemia","Children and Young People","ALLTogether","2025-02-22",{"date":455,"type":36},"2025-02-26",{"date":457,"type":20},"2025-04-01",{"date":459,"type":20},"2029-12-31",{"name":42,"class":43},{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":21,"phases":470,"briefSummary":471,"conditions":472,"keywords":474,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":485,"locationsCount":105},"100572423","development-of-digital-services-for-parkinsons-disease-100572423","NCT06733077","Development of Digital Services for Parkinson's Disease","Development of Digital Diagnostics and Intervention Services for Parkinson's Disease","Inclusion criteria Participants with Parkinson's \\[Phase 1,2,3,4\\]\n\n* Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale \\[stroke, multiple sclerosis, arthritis or osteoporosis\\]\n* Able to self-report history of daily gait freezing and\u002For festination for people with PD or gait and\u002For transfers affected by condition\n* Able to walk unsupported or using an aid for at least 5 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands\n\nHealthy participants \\[Phase 1,2,3\\]\n\n* With no long-term conditions affecting movement\n* Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands\n\nExclusion criteria Participants with Parkinson's\n\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implant that may interfere with the measurement system\n* Medications likely to affect eye sight or use of virtual reality sytstem\n\nHealthy participants\n\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system",{"count":469,"type":20},80,[23],"In this project, ocular motor, pupil and gait data in people with Parkinson's disease (PD) will be collected in order to develop machine learning models for the diagnosis and monitoring of PD. With this, the investigators aim to advance the state of the art in PD diagnosis and monitoring. By integrating the principles of machine learning with high-quality sensor data, more accurate and earlier diagnosis could potentially be achieved. Ocular motor and pupil data will be collected with the standard clinical examination and with neos, a medical device approved for objective ocular motor and pupil measurement. Gait will be collected using an IMU sensor and GaitQ senti, a consumer device that allows for an objective and continuous remote gait monitoring.",[473,265],"Healthy Controls",[475,476,477,478],"gaitQ","long-term movement condition","digital healthcare","MachineMD","2025-01-29",{"date":481,"type":36},"2025-02-03",{"date":483,"type":36},"2024-12-20",{"date":134,"type":20},{"name":42,"class":43},{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":466,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":493,"conditions":494,"keywords":513,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":4},"100557135","digital-diagnostics-and-intervention-services-for-parkinsons-disease-100557135","NCT06534177","Digital Diagnostics and Intervention Services for Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale \\[stroke, multiple sclerosis, arthritis or osteoporosis\\]\n* Able to self-report history of daily gait freezing and\u002For festination for people with PD or gait and\u002For transfers affected by condition\n* Able to walk unsupported or using an aid for at least 5 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands Healthy participants \\[Phase 1,2,3\\]\n* With no long-term conditions affecting movement\n* Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and\n* if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands\n\nExclusion Criteria:\n\n* Participants with long-term conditions affecting movement\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand\n* testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implant that may interfere with the measurement system Healthy participants\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand\n* testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system",{"count":469,"type":20},"People with Parkinson's have infrequent clinical consultation (once every 12-18 months) and limited rehabilitation.\n\nAssessment play an important role in these consultations to help clinicians understand patients' health status and disease progression necessary to adjust treatment plans. The current way of measuring is the UPDRS which needs a clinician to do this and takes 30 minutes. There is a strong need for more frequent and accurate Parkinson's assessments in the clinic and at home to detect changes early and then give appropriate support and drug and physiotherapy quickly. There is a need to develop good home digital physiotherapy tools to increase the amount of therapy. Here the investigators are testing new digital technologies to do these assessments in the home and clinic and a new digital physiotherapy device in the home. The investigators aim to conduct a clinical study with 50 people with Parkinson's (50 from UK) with the UPDRS, (a rating scale that is commonly used in clinical settings to evaluate the progression of Parkinson's disease) and 30 healthy adults. The investigators will develop and investigate if two new digital devices, one the MachineMD that measures eye movement and one the gaitQ that measures gait can be used instead of the MDS-UPDRS (motor) using digital gait and ophthalmic features in the clinic setting. The investigators will investigate the effect of a physiotherapy gait intervention gaitQ Tempo in the home context for two weeks and of doing the gait measure at home. The investigators will determine the potential of the gaitQ intervention to improve key gait metrics in order to collect clinical evidence and of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community",[495,496,497,498,499,239,500,501,502,503,504,505,506,507,508,509,510,511,512],"Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Joint Diseases","Musculoskeletal Diseases","Basal Ganglia Diseases","Movement Disorders","Synucleinopathies","Neuro-Degenerative Disease","Demyelinating Disease, Autoimmune, CNS","Demyelinating Disease","Autoimmune Diseases","Immune System Diseases","Bone Diseases, Metabolic","Bone Diseases","Arthritis","Osteoporosis","Multiple Sclerosis",[514,515,28,516,517],"parkinson's disease","osteoarthritis","MS","osteoporosis","2024-08-06",{"date":520,"type":36},"2024-08-09",{"date":522,"type":20},"2024-10-15",{"date":428,"type":20},{"name":42,"class":43},{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":343,"enrollmentInfo":532,"targetDuration":4,"studyType":21,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":105},"100546209","spirulina-supplementation-in-recovery-from-damaging-exercise-100546209","NCT06391957","Spirulina Supplementation In Recovery From Damaging Exercise","SPIRAL","Inclusion Criteria:\n\n* Are available and willing to attend St Luke's Campus, Exeter\n* Age 18 - 40\n* BMI 18.5 - 30 kg\u002Fm2\n* The participant exercises \u002F plays sport for \\> 2 h\u002Fweek, but doesn't do structured resistance strength training\n* Self-reported as healthy (absence of injury or disease)\n* Have no known food allergy to algae\n* Are not taking any over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication\n* Non-smoker\n\nExclusion Criteria:\n\n* Are unable to attend St Luke's Campus, Exeter\n* Are out-with age range 18 - 40\n* BMI below 18.5 or above 30 kg\u002Fm2\n* The participant does not exercise\n* The participant does regular structured resistance strength training\n* Known injury or disease that might influence study outcomes\n* Have a known food allergy to algae\n* Are taking over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication\n* Smoker",{"count":295,"type":20},[23],"Exercise can cause muscle damage, leading to a loss in muscle function, increased muscle soreness and inflammation. Evidence supports the use of nutritional strategies to help recovery. Spirulina is a type of algae. It is eaten as a food supplement as it is full of micronutrients, some which provide anti-inflammatory benefits. This work will assess the impact of taking spirulina supplements on recovery from hard exercise. Investigators will measure changes in muscle function, soreness and markers of inflammation.",[536],"Damage Muscle",[538,539],"spirulina","exercise recovery","2024-06-13",{"date":542,"type":36},"2024-06-14",{"date":544,"type":36},"2024-01-04",{"date":546,"type":20},"2024-09-30",{"name":42,"class":43},""]