[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-adult-participants\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-adult-participants":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,50,0,25,[9,50,80,116,139,169,189,210,233,253,283,302,330,352,374,399,419,439,461,492,522,542,570,598,622],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100645164","postprandial-regulation-of-bone-perfusion-in-healthy-individuals-100645164",false,"NCT07679516","Postprandial Regulation of Bone Perfusion in Healthy Individuals","GA-27","Inclusion Criteria:\n\n1. Age 25-50 years.\n2. BMI between 18.5-30 kg\u002Fm2.\n3. Normal gait.\n4. Premenopausal (if female).\n5. Informed consent.\n\nExclusion Criteria:\n\n1. Bone disease incl. confirmed osteopenia.\n2. Fracture within the last 6 months at the time of inclusion.\n3. Amputation or congenital defect of extremities.\n4. HbA1c\\>41.9 mmol\u002Fmol and\u002For diagnosed type 1 or type 2 diabetes.\n5. Any ongoing or prior medication that the investigator evaluates could interfere with the endpoints of the study (e.g. glucocorticoids or other medications that may compromise bone health).\n6. Pregnancy or breastfeeding (or plans thereof within the study duration).\n7. Not using effective hormonal contraceptives or an intra uterine device within study duration (e.g. oral contraceptives, transdermal patch, vaginal ring, Depo-Provera injections, Nexplanon implant).\n8. Ongoing or prior alcohol abuse (defined per ICD-10 classification for alcohol dependence syndrome, F10.21) or daily alcohol intake\n9. Use of any illicit substance or narcotics within three months of inclusion, including within study duration.\n10. Any physical or psychological condition that the investigator evaluates would interfere with trial participation.\n11. Recent (three months prior to inclusion), ongoing or planned weight loss within study duration (weight loss defined as exceeding -5% bodyweight, or intentional hypocaloric dieting)",true,"ALL","25 Years","50 Years",{"count":22,"type":23},15,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this clinical trial is to learn whether certain natural hormones - Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2, (GLP-2), and amylin - affect blood flow to the bones.",[29,30,31,32,33,34,35,36],"Healthy Adult Participants","Bone Physiology","Bone Blood Flow Regulation","GLP-2","GIP","Amylin","Peptide Hormones","Gut Hormones","NOT_YET_RECRUITING","2026-06-25",{"date":40,"type":41},"2026-07-01","ACTUAL",{"date":43,"type":23},"2026-07-19",{"date":45,"type":23},"2028-05",{"name":47,"class":48},"University of Copenhagen","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"100645084","evaluation-of-applex-apple-extract-on-anti-inflammatory-and-healthy-aging-effects-100645084","NCT07678346","Evaluation of AppleX™ Apple Extract on Anti-Inflammatory and Healthy Aging Effects","A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Anti-Inflammatory and Healthy Aging Effects of AppleX™ Apple Extract (15% Fisetin) in Adults 45-70 Years of Age","Inclusion Criteria:\n\n* Age 45-70 years at time of enrollment\n* Meets questionnaire-based inflammatory enrichment criteria (at least 2 of 5 risk factors, per Section 4.2)\n* Non-smoker (no tobacco or nicotine use within 6 months of enrollment)\n* Willing and able to maintain stable diet, exercise habits, and supplement use throughout the 24-week study period\n* No major medication changes planned during the study period\n* Willing to perform home-based DBS collections at T0, T12, and T24\n* Access to a smartphone or computer to complete eConsent and online questionnaires\n* Able to provide informed consent via the Alethios eConsent platform\n\nExclusion Criteria:\n\n* Current use of prescription anti-inflammatory medications including NSAIDs (regular use ≥3x\u002Fweek), corticosteroids, or DMARDs\n* Diagnosis of an autoimmune or inflammatory disease (e.g., rheumatoid arthritis, lupus, IBD, multiple sclerosis)\n* Active or unstable cardiovascular disease requiring medication changes during the study period\n* History of cancer within the past 5 years (except non-melanoma skin cancer)\n* Regular use of supplemental fisetin, quercetin, or resveratrol within 30 days of enrollment\n* Pregnancy, breastfeeding, or planning to become pregnant during the study\n* Known allergy to apple or apple-derived products\n* Body mass index (BMI) \\>40 kg\u002Fm²","45 Years","70 Years",{"count":60,"type":23},70,[26],"The goal of this clinical trial is to learn if AppleX™ Apple Extract can help lower systemic inflammation in adults aged 45-70 with signs of low-grade inflammation. It will also look at the extract's effects on fatigue, joint comfort, and biological aging metrics.\n\nThe main questions it aims to answer are:\n\n* Does taking AppleX™ Apple Extract daily lower high-sensitivity C-reactive protein (hsCRP) levels, a key marker of inflammation in the blood?\n* Does AppleX™ Apple Extract improve participant-reported fatigue and joint comfort?\n* Does the extract slow down biological or epigenetic aging metrics compared to a placebo?\n\nResearchers will compare AppleX™ Apple Extract to a placebo (a look-alike capsule that contains no active ingredients) to see if the apple extract has a measurable anti-inflammatory and healthy aging effect.",[64,65,66,29],"Systemic Inflammation (hsCRP)","Healthy Aging","Vitality",[68,69,70,71],"Apple extract","Fisetin","Flavonoids","polyphenols",{"date":40,"type":41},{"date":74,"type":23},"2026-07",{"date":76,"type":23},"2027-02",{"name":78,"class":79},"Nutraland USA, Inc.","INDUSTRY",{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":24,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":49},"100629334","phase-1-evaluation-of-mtx-439-in-healthy-adults-and-adults-with-diabetic-kidney-disease-100629334","NCT07473323","Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease","A Phase 1 Randomized, Double-blind, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease","Inclusion Criteria:\n\n1. All genders, ages 18 to 65 years, inclusive.\n2. Able to read and understand the study and all related materials (including the ICF), and provide a signed, written informed consent.\n3. Willing and able to complete all protocol-required study visits and procedures.\n4. Consumption of no more than 5 cigarettes or other cotinine-containing products (including tobacco, nicotine gum, patches, nicotine pouches, and e-cigarettes) per week and agreement to abstain from all such products during inpatient stays.\n5. Willing to refrain from marijuana- or cannabinol-containing products for 30 days before Screening and until the last study visit.\n6. Agrees to not donate eggs (if applicable) from the time of the first infusion until 65 days after the final dose, or 125 days after the final dose for sperm (if applicable); additionally agrees to not donate blood from 56 days prior to the time of first infusion until 90 days after the last study visit or platelets\u002Fplasma from 14 days prior to the time of first infusion until 90 days after the last study visit.\n7. Participants are required to follow specific contraception measures as follows:\n\n   * Participants assigned male at birth must use a condom (even if vasectomised) at the time of Screening and for 125 days after the final dose.\n   * Participants assigned female at birth must be of nonchildbearing potential (defined as either at least 6 months surgically sterilised or at least 1 year postmenopausal and confirmed by follicle-stimulating hormone \\[FSH\\] level \\> 40 U\u002FL) OR, if of childbearing potential (defined as not sterilised via bilateral oophorectomy or hysterectomy; still menstruating; or \\\u003C 1 year has passed since the last menses, if menopausal), must use a combination of 1 highly effective method of contraception and 1 effective method of contraception. This contraceptive practice should begin at least 28 days before the first dose of study drug, continue during the study, and persist for 65 days after the final dose of study drug, if applicable.\n   * Male participants agree to ensure that their female partners who are of childbearing potential will use a highly effective method of contraception..\n8. Vital signs within the following ranges:\n\n   * Systolic blood pressure: 90-140 mmHg\n   * Diastolic blood pressure: \\\u003C 90 mmHg\n   * Pulse rate: 55-100 bpm\n   * Respiration rate: 10-16 respirations per minute\n\n   DKD participants:\n9. All of the above.\n\n   * Well-controlled diabetes requiring minimal dose adjustments of antidiabetic medications in the past 3 months and no adjustments within 30 days of Screening.\n   * Haemoglobin A1C \\\u003C 9.5%.\n   * Estimated glomerular filtration rate (eGFR) between 30 and 60.\n\nExclusion Criteria:\n\n1. Any active medical condition determined clinically significant by the Investigator, except for DKD (for DKD participants).\n2. Body mass index (BMI) \\> 32 kg\u002Fm2 for healthy participants; \\> 40 kg\u002Fm2 for DKD participants.\n3. Use of any systemic immunosuppressant medications, medications to treat diabetes (except DKD participants), antipsychotics, anticoagulants, or other prescription medications other than contraceptives within 90 days of Screening that, as determined by the Investigator, could confound their participation in the study.\n4. Received a vaccine within 30 days of Screening.\n5. Cancer or a history of cancer or lymphoproliferative disorder within 5 years of Screening except for adequately treated non-melanoma cancers of the skin and cervical carcinoma in situ.\n6. Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) as evidenced by a positive hepatitis B surface antigen (HbsAg) test at Screening or a positive HIV test at Screening. For hepatitis C, a positive hepatitis C antibody (antiHCV) test is exclusionary unless the participant has previously been treated for hepatitis C, in which case they would be eligible with a negative HCV ribonucleic (RNA) test.\n7. Currently pregnant, lactating, or planning to conceive or contribute to pregnancy during the trial and up to 65 days (for participants of childbearing potential) or 125 days (for males) after the participant's last dose of study drug, if applicable.\n8. History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 5 years of Screening.\n9. History of anaphylaxis or other significant allergies in the opinion of the Investigator.\n10. History of substance use disorder as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within 1 year of Screening.\n11. Positive screen for drugs of abuse or alcohol at Screening or admission to the CRU (Day -1).\n12. Donation of blood within 28 days of Screening.\n13. Any clinically significant disease or laboratory abnormality detected at Screening, including diabetes mellitus, that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety, including the following:\n\n    * Haemoglobin \\\u003C 115 g\u002FL (female) or \\\u003C 135 g\u002FL (male); \\> 160 g\u002FL (female) or \\> 180 g\u002FL (male)\n    * Absolute neutrophils \\\u003C 2.0 × 109\u002FL or \\> 7.5 × 109\u002FL\n    * White blood cells \\\u003C 4.0 × 109\u002FL or \\> 11.0 × 109\u002FL\n    * Platelet count \\\u003C 150 × 109\u002FL or \\> 450 × 109\u002FL\n    * Any clinically significant abnormality on any of the Screening ECGs\n    * Alanine aminotransferase or aspartate aminotransferase greater than 1.2 times the upper limit of normal.\n14. Any surgical procedure, including planned procedures within 12 weeks of Screening.\n15. Known allergy to MTX-439 or any of its excipients.\n16. Participation in another research study of an investigational agent within 30 days of Screening or 5 half-lives of the agent, whichever is longer.","18 Years","65 Years",{"count":90,"type":23},88,[92],"PHASE1","This is a phase 1 randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and Pharmacokinetics (PK) of single and multiple ascending doses of MTX-439 administered in healthy adults and adults with diabetic kidney disease (DKD)",[29,95],"Diabetic Kidney Disease",[97,98,99,95,100,101,102,103,104,105,106],"MTX-439-K101","MTX-439","Healthy Volunteers","HV","DKD","Adult","Monoclonal Antibody","SMOC2","SAD","MAD","RECRUITING",{"date":109,"type":41},"2026-06-29",{"date":111,"type":41},"2026-05-19",{"date":113,"type":23},"2028-01",{"name":115,"class":79},"Mediar Therapeutics",{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":24,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":49},"100643957","phase-1-a-phase-i-study-of-ns-079-in-healthy-participants-100643957","NCT07669571","A Phase I Study of NS-079 in Healthy Participants","A Phase I, Double-blind, Placebo-controlled Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of NS-079 in Healthy Participants","Inclusion Criteria\n\n1. Healthy males or females aged 18-55 years (inclusive), with a body mass index (BMI) between 18.00 and 32.00 kg\u002Fm2(inclusive) at screening.\n2. Not participated in any other clinical trials and received an investigational drug or device within the past 30 days or 5 half-lives prior to screening, whichever is longer.\n3. Women of non-childbearing potential (WONCBP) (as defined in Appendix 1); women of childbearing potential (WOCBP) who are abstinent from heterosexual intercourse as a preferred and usual lifestyle choice, or who agree to use highly effective contraception (as defined in Appendix 1) in combination with a condom from the time of signing the informed consent form until at least 90 days after the last dose of investigational product, agree to refrain from ova donation during this period, and return a negative pregnancy test at screening and baseline (Day -1).\n4. Surgically sterile males (with verbal confirmation of the absence of sperm in the ejaculate); males who are abstinent from heterosexual intercourse as a preferred and usual lifestyle choice, or who agree to use highly effective contraception with a female partner (as defined in Appendix 1) in combination with a condom from the time of signing the informed consent form until at least 90 days after the last dose of investigational product, and agree to refrain from sperm donation during this period.\n5. In good health, determined by the investigator\u002Fdelegate on the basis of medical history, physical examinations, vital signs, electrocardiograms (ECGs), clinical laboratory tests (hematology, coagulation, urinalysis, blood biochemistry). Repeated examination is allowed once per timepoint at the investigator\u002Fdelegate's discretion.\n6. Full understanding of the purpose, nature, procedures of the study, and the potential adverse reactions. Participant voluntarily participates and signs the informed consent form before any study procedures begin.\n7. Agree to provide a biological sample (blood or saliva\u002Fbuccal swab, per site capability) for Cytochrome P450 2D6 (CYP2D6) pharmacogenetic genotyping during the screening period, and the genotyping results must be available prior to randomization and dosing.\n8. Participants must be confirmed CYP2D6 Normal Metabolizers (NM) or Intermediate Metabolizers (IM) based on pharmacogenetic genotyping. For Part 3 \\[DDI\\] participants only: Must have a confirmed CYP2D6 NM status based on pharmacogenetic genotyping.\n\nExclusion Criteria\n\n1. Known hypersensitivity or allergy to the investigational product, its excipients, or any of its components, or a history of clinically significant allergic reactions that, in the opinion of the investigator\u002Fdelegate, may place the participant at increased risk.\n2. Known hypersensitivity to or severe intolerance of paroxetine or any SSRI (including serotonin syndrome or discontinuation syndrome) (for Part 3 \\[DDI\\] only).\n3. Unable to refrain from all known CYP2D6 substrate medications (including over-the-counter (OTC) medications such as dextromethorphan-containing cough and cold preparations) during paroxetine dosing (for Part 3 \\[DDI\\] only). Final clinical judgment on individual concomitant medications remains with the investigator\u002Fdelegate.\n4. Individuals with a history of intolerance to venipuncture or venous catheterization (e.g., recurrent syncope during blood draws or significant needle phobia) that, in the opinion of the investigator\u002Fdelegate, may interfere with the study procedures.\n5. Positive serologic test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV) or human immunodeficiency virus antibody (Anti-HIV) at Screening.\n6. Average daily smoking of more than 5 cigarettes per day in the 3 months prior to Screening, or inability or unwillingness to abstain from the use of tobacco or nicotine-containing products (including cigarettes, e-cigarettes, vaping products, and nicotine replacement products) from 48 hours prior to the first dose through completion of the final safety follow-up visit.\n7. Excessive alcohol consumption, defined as average weekly alcohol intake exceeding 14 units during the 4 weeks prior to Screening (1 unit ≈10 g of pure alcohol; 1 alcohol unit is equal to 375ml 3.5% beer, 100 mL of wine, or 30 mL of 40% spirit), unwillingness or inability to abstain from alcohol and alcohol-containing products from 48 hours prior to the first dose through the completion of the final safety follow-up visit, or a positive alcohol breath test at Screening or upon admission to the clinical unit. (A repeat test may be performed once per timepoint at the investigator\u002Fdelegate's discretion).\n8. Excessive consumption of caffeinated beverages (e.g., coffee, tea, energy drinks), defined as an average of \\>8 cups\u002Fday (1 cup ≈ 250 mL) within 3 months prior to screening, or unwillingness or inability to refrain from caffeinated beverages from 48 hours prior to the first dose through the end of the inpatient confinement phase.\n9. Unwillingness or inability to abstain from grapefruit or grapefruit containing products, Seville (bitter) oranges, or pomelo\u002Fpomelo-containing products from 7 days prior to the first dose through the end of the inpatient confinement phase.\n10. Use of classic psychedelics or hallucinogenic substances with primary 5-HT2A agonist activity (e.g., lysergic acid diethylamide \\[LSD\\], psilocybin\u002Fmagic mushrooms, dimethyltryptamine \\[DMT\\], ayahuasca, mescaline) on 5 or more occasions lifetime, or any use within 5 years prior to Screening.\n11. Current or past substance use disorder (including alcohol or drugs of abuse) within the 12 months prior to Screening, as judged by the investigator\u002Fdelegate; use of ketamine or phencyclidine (PCP) for recreational or non-prescribed purposes within 12 months prior to Screening; use of cannabis within 6 weeks prior to Screening; use of other illicit drugs or non-prescribed psychoactive substances (including but not limited to MDMA, cocaine, opiates, amphetamines) within 4 weeks prior to Screening; or a positive drug of abuse urine screen at Screening or upon admission. Single or occasional use prior to the applicable washout period may be permitted at the investigator\u002Fdelegate's discretion, provided the urine drug screen is negative. A repeat drug screen may be performed once per timepoint at the investigator\u002Fdelegate's discretion.\n12. History or presence of the following conditions:\n\n    1. . Clinically significant (as judged by the investigator\u002Fdelegate) neurological or psychiatric disorders, defined as any of the following: history of epilepsy or any seizure disorder (excluding childhood febrile seizures); history of dementia or any clinically diagnosed cognitive disorder; clinically significant migraine, defined as: history of migraine with aura; chronic migraine (≥4 migraine days\u002Fmonth on average over the past 6 months); or use of prophylactic migraine medication or triptans within 30 days prior to first dose; any current or lifetime clinical diagnosis of schizophrenia spectrum or other psychotic disorder, bipolar I or II disorder, or borderline personality disorder; clinically significant depression, defined as: any current or lifetime clinical diagnosis of major depressive disorder or other depressive disorder; any history of pharmacological treatment for depression; any current clinical diagnosis of anxiety disorder or any history of pharmacological treatment for anxiety within 1 year prior to screening; or any history of psychiatric hospitalization. Neurological and psychiatric history will be assessed at Screening through clinical interview by the investigator\u002Fdelegate, supplemented by review of available medical records.\n    2. . Clinically significant (as judged by the investigator\u002Fdelegate) cardiovascular disorders, including history of prolonged QTc interval (defined as QTcF \\>450 ms for males or \\>470 ms for females, or any clinically significant ECG abnormality); or chronic cardiovascular diseases (specifically including history of cardiac valvulopathy or pulmonary hypertension or hypertension); or current hypertension (resting systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\>90 mmHg). Blood pressure assessment can be repeated at the discretion of the investigator\u002Fdelegate.\n    3. . Clinically significant (as judged by the investigator\u002Fdelegate) systemic diseases or conditions, including immunodeficiency or immunosuppressive disorders; malignant neoplastic diseases; or clinically significant endocrine, respiratory, hematologic (including coagulation), or digestive system diseases that may interfere with the safety of the participant or the interpretation of study results.\n    4. . Any of the following laboratory or medical history findings: AST or ALT \\>2 × ULN, or known or suspected Gilbert's Syndrome; eGFR \\\u003C60 ml\u002Fmin\u002F1.73m2; History of cholecystectomy.\n13. Family history of a psychotic disorder (including schizophrenia, schizoaffective disorder, or bipolar disorder) in a first-degree relative.\n14. Clinically significant (as judged by the investigator\u002Fdelegate) current or past suicidality based on the Columbia-Suicide Severity Rating Scale (C-SSRS), or psychiatric history indicating current suicidal ideation, or a history of active suicidal ideation or suicide attempts.\n15. Underwent major surgery within the past 6 months prior to the first dose (such as coronary artery bypass grafting, hepatectomy, gynecological surgery, etc.)\n16. Occurrence of acute neurological, digestive, respiratory, cardiovascular, endocrine, hematological, or other systemic diseases that may affect the absorption, distribution, metabolism, excretion, and safety evaluation of the investigational product within 3 months prior to screening judged by investigator\u002Fdelegate.\n17. Donation of blood or experienced blood loss ≥400 mL within the 3 months prior to the first dose; difficulties in venous blood collection; planned blood donation during the study or within 30 days after the study.\n18. Use of any prescription or non-prescription medications, including over-the-counter (OTC) medications within 14 days or 5 elimination half-lives (whichever is longer) prior to the first dose; use of any herbal products or nutritional\u002Fdietary supplements within 21 days prior to the first dose, except paracetamol (≤2 g per day); and use of any central nervous system acting drugs (including monoamine oxidase inhibitors \\[MAOIs\\], SSRIs), serotonergic supplements (e.g., St. John's Wort, 5-hydroxytryptophan \\[5-HTP\\], L-tryptophan), or strong\u002Fmoderate CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine (prior use prohibited; protocol-directed administration as CYP2D6 index inhibitor in Part 3 \\[DDI\\] only), quinidine, terbinafine, duloxetine, cinacalcet) within 30 days or 5 elimination half-lives (whichever is longer) prior to the first dose. For Part 3 \\[DDI\\] only: Unwillingness or inability to abstain from NSAIDs (e.g., ibuprofen, naproxen, diclofenac) or aspirin throughout the paroxetine dosing and washout period; paracetamol (≤2 g\u002Fday) is the only permitted analgesic during this period.\n19. Receipt of vaccines within the 4 weeks prior to the first dose of the investigational product.\n20. Other factors deemed unsuitable for participation in the trial by the investigator\u002Fdelegate.","55 Years",{"count":125,"type":23},78,[92],"The goal of this clinical trial is evaluate the safety, pharmacokinetics, and pharmacodynamics of NS-079 with its main metabolite (NS-079-M1) in healthy participants. The main questions it aims to answer are:\n\n* Is NS-079 safe and tolerable in heathy participants under tested dosing regimen?\n* What is the pharmacokinectic profile of NS-079 in healthy participants under tested dosing regimen and the effect of paroxetine? Researchers will compare NS-079 to a placebo to see the safety and tolerability when use NS-079.",[29],[130],"5-HT2A receptor","2026-06-22",{"date":38,"type":41},{"date":134,"type":23},"2026-06",{"date":136,"type":23},"2027-05",{"name":138,"class":79},"NeuShen Therapeutics",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":24,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":49},"100644091","oil-pulling-whitening-mouthwash-100644091","NCT07667088","Oil Pulling Whitening Mouthwash","Evaluation of Tooth Whitening Efficacy of GuruNanda Oil Pulling Oral Rinse.","Inclusion Criteria:\n\n1. Adult subjects aged 18-60, that are in good health.\n2. Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator.\n3. Subject's front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachguide 3D-Master and the Vita EasyShade device.\n4. Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.\n5. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other teeth whitening technologies during this period.\n6. The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.\n\nExclusion Criteria:\n\n1. Pregnant or nursing by subject report.\n2. Known allergic reaction to any of the study mouthwashes or any of their components. Participant has completed the screening questionnaire (Exclusion due to Known Allergens).\n3. Any active condition in the oral cavity at the discretion of the investigator.\n4. Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.\n5. Subjects that do not brush regularly.\n6. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.\n7. Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.\n8. Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.\n9. Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).\n10. Participation in another clinical trial within the last 30 days.\n11. Presence of orthodontic appliances, except for removable retainers.\n12. Signs of advanced enamel wear, dentin exposure, or tooth fractures.","60 Years",{"count":148,"type":23},120,[26],"The goal of this study is to evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo). Each participant will use one of three mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). All mouthwashes will be used once daily last thing before bed at night. Data will be collected on tooth shade evaluated on the anterior teeth.",[29,152],"Tooth Stain",[154,155,156,157,158,159],"tooth whitening","tooth stains","oil pulling","mouthwash","mouth rinse","stain removal","2026-06-18",{"date":162,"type":41},"2026-06-24",{"date":164,"type":41},"2026-05-01",{"date":166,"type":23},"2026-08-31",{"name":168,"class":48},"The University of Texas Health Science Center at San Antonio",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100644272","global-reference-ranges---mexico-100644272","NCT07664982","Global Reference Ranges - Mexico","Global Reference Ranges (GRR) for Magnetic Resonance Imaging of Intra-abdominal Organs in Healthy Adults From Different Ethnic Groups - Mexico","GRR Mexico","Inclusion Criteria:\n\n* Male or female at least 18 years of age\n* Self-reported healthy\n* Willing and able to give informed consent for participation in the study\n* Willing and able to undergo an MRI\n\nExclusion Criteria:\n\n* History of cardiovascular disease as follows:\n\n  * Myocardial infarction\n  * Heart failure\n  * Cardiomyopathy\n  * Stroke\n  * Hospital admission\u002Fdischarge for unstable angina\n  * Heart surgery\n  * Unstable angina\n  * Transient ischemic attack\n* Presence of CVD risk factors such as hypertension, hyperlipidaemia, Type 2 diabetes, BMI \\> 30 kg\u002Fm2, smoker (current\u002Fex-smoker)\n* History of non-cardiac diseases related to the lungs, liver, kidneys, pancreas or spleen judged by the study investigator as therefore unsuitable to participate in the study\n* The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MRI exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia)\n* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study",{"count":5,"type":23},"OBSERVATIONAL","The investigators aim to undertake the Global Reference Range Study (GRR) to establish a set of healthy adult reference values for measures of fibroinflammation, fat and size\u002Fvolumes for the liver, and other abdominal and thoracic organs to assess, compare, and if necessary, propose ethnicity specific reference ranges for these measurements.",[29],"2026-06-17",{"date":162,"type":41},{"date":184,"type":23},"2026-08",{"date":186,"type":23},"2029-08",{"name":188,"class":79},"Perspectum",{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":57,"enrollmentInfo":196,"targetDuration":4,"studyType":24,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":49},"100599208","phase-1-phase-1-study-of-adx-626-in-healthy-participants-100599208","NCT07081503","Phase 1 Study of ADX-626 in Healthy Participants","A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants","Key Inclusion Criteria:\n\n* Age 18 to 45 years at the time of informed consent\n* Males or women of non-childbearing potential (WONCBP)\n* Willing to comply with all study requirements while participating\n* Suitable venous access for blood sampling.\n* Body weight ≥ 50 kg and a body mass index (BMI) ≤25 kg\u002Fm2\n* Normal laboratory results including liver enzymes, hemoglobin, platelet count, and coagulation parameters\n* Willing to use acceptable contraception methods if applicable\n\nKey Exclusion Criteria:\n\n* Significant medical condition such as hypertension, diabetes, cardiovascular disease, or cancer\n* History of bleeding or coagulation disorders, prior instances of major bleeding, or a family history of bleeding disorders.\n* Current infection\n* Participation in an interventional drug study within the last 90 days",{"count":197,"type":23},44,[92],"This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).",[29],"2026-06-12",{"date":203,"type":41},"2026-06-16",{"date":205,"type":41},"2025-08-12",{"date":207,"type":23},"2027-01-22",{"name":209,"class":79},"ADARx Pharmaceuticals, Inc.",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":57,"enrollmentInfo":217,"targetDuration":4,"studyType":24,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":231,"locationsCount":49},"100642534","phase-1-a-clinical-trial-of-multiple-doses-of-gr2301-injection-in-healthy-adult-trial-participants-in-china-100642534","NCT07647224","A Clinical Trial of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.","A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity Profiles of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.","Main Inclusion Criteria:\n\n1. BMI 19.0-28.0 kg\u002Fm², with male subjects weighing ≥50.0 kg and female subjects weighing ≥45.0 kg；\n2. Understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form.\n\nMain Exclusion Criteria:\n\n1. A history of past or current conditions involving the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, endocrine system, metabolic system, or other clearly documented medical conditions, which the investigator deems may pose a risk to the subject's safety or interfere with the conduct, progress, or completion of the trial.\n2. History of drug use or substance abuse, or positive urine drug screening prior to enrollment.\n3. Pregnant and breastfeeding women.",{"count":218,"type":23},36,[92],"This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and immunogenicity characteristics of GR2301 injection in healthy adult subjects in China. The Multiple doses will be gradually escalated.",[222,29],"Multiple Dose",[224],"IL15","2026-06-09",{"date":227,"type":41},"2026-06-15",{"date":134,"type":23},{"date":230,"type":23},"2027-07",{"name":232,"class":79},"Genrix (Shanghai) Biopharmaceutical Co., Ltd.",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":239,"targetDuration":4,"studyType":24,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100643317","the-seas-study-sensory-engagement-and-activation-during-noninvasive-stimulation-100643317","NCT07606573","The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation","Inclusion Criteria:\n\n* Able to provide written informed consent in English.\n* Willing and able to complete study procedures (e.g., \\~1-hour sessions with non-invasive recordings, \\~3-hour visit).\n\nExclusion Criteria:\n\n* History of neurological disorders (e.g., epilepsy, migraines) or psychiatric conditions requiring medication.\n* Active implanted medical devices (e.g., pacemakers, cochlear implants) or metal in the neck\u002Fforearm that could interfere with stimulation or recordings.\n* Skin conditions or open wounds at stimulation sites (cervical neck, forearm).\n* Women who are pregnant or breastfeeding.\n* Current use of medications affecting autonomic or cortical function (e.g., beta-blockers, sedatives).\n* Inability to sit still for recordings or understand instructions (e.g., due to severe vision\u002Fhearing impairment).",{"count":240,"type":23},40,[26],"Early feasibility study to establish quantitative physiological markers correlated with noninvasive stimulation.",[29],{"date":245,"type":41},"2026-06-11",{"date":247,"type":41},"2026-06-08",{"date":249,"type":23},"2028-02",{"name":251,"class":48},"University of Minnesota",3,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":24,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":281,"locationsCount":49},"100631253","location--and-frequency-dependent-effects-of-thalamic-temporal-interference-stimulation-during-sleep-100631253","NCT07498270","Location- and Frequency-Dependent Effects of Thalamic Temporal Interference Stimulation During Sleep","CAP-TI","Inclusion Criteria:\n\n* Medically healthy (based on self-report and study team review)\n* U.S. citizen or holding permanent resident status\n* English-speaking (able to provide consent and complete questionnaires)\n\nExclusion Criteria:\n\n* Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified in first MRI)\n* History of inpatient psychiatric hospitalization\n* History of head trauma resulting in prolonged loss of consciousness; or a history of greater than 3 grade I concussions\n* Current history of poorly controlled headaches including intractable or poorly controlled migraines\n* Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist\n* Possible pregnancy or plan to become pregnant in the next 6 months (self reported)\n* Any metal in the head\n* Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)\n* Dental implants\n* Permanent retainers\n* Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions\n* Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions\n* Any medication that may alter seizure threshold taken during the study i.e., ADHD stimulants (Adderall, amphetamine); Tricyclic\u002Fatypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, bupropion); SSRIs (Escitalopram, Fluoxetine, Sertraline); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); OTC antihistamines (diphenhydramine, Benadryl)\n* Claustrophobia (a fear of small or closed places)\n* Back problems that would prevent lying flat for up to two hours\n* Regular night-shift work (second or third shift)\n* Sleep apnea or other sleep disorder (self-reported)","40 Years",{"count":262,"type":23},24,[26],"This study is to find out whether a type of non-invasive electrical brain stimulation called temporal interference transcranial electrical stimulation (TI-TES) can temporarily change brain activity during sleep, especially sleep spindles (brain rhythms in the \\~8-16 Hz range). Up to 24 healthy participants in Dane County, Wisconsin will be enrolled for 3 overnight study visits. Participants can expect to be on study for approximately 5 weeks, depending on scheduling availability.",[29,266],"Healthy Participants",[268,269,270,271,272,273,274,275],"sleep","spindles","non-rapid eye movement","SSD","neurobiology","impairment","brain stimulation","non-invasive stimulation",{"date":277,"type":41},"2026-06-10",{"date":279,"type":41},"2026-06-05",{"date":249,"type":23},{"name":282,"class":48},"University of Wisconsin, Madison",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":146,"enrollmentInfo":290,"targetDuration":4,"studyType":24,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":49},"100642787","phase-1-a-study-of-nhl907-in-healthy-adult-participants-100642787","NCT07580924","A Study of NHL907 in Healthy Adult Participants","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of NHL907 Combination Drug Following Multiple Oral Doses in Healthy Adult Participants","Inclusion Criteria:\n\n1. Healthy adult male and female participants aged between 18 and 60 years of age, inclusive.\n2. Has a body mass index (BMI) between ≥ 18 and ≤ 32 kg\u002Fm2 inclusive, with body weight ≥ 50 kg at Screening.\n3. Able and willing to understand and sign the informed consent form, communicate meaningfully with study personnel, and comply with all study restrictions, procedures, laboratory tests, and other study requirements.\n4. In good health, determined by the Investigator on the basis of medical history, physical examination, vital signs, Screening laboratory results, Screening ECG, and mental status.\n5. Participants of non-childbearing potential should be congenitally or surgically sterile or in a menopausal state as confirmed by follicle-stimulating hormone (FSH) concentrations (≥ 40 IU\u002FL at Screening).\n6. Female participants with childbearing potential must agree to use accepted contraceptive regimens from time of Screening, during the study, and for at least 60 days after end of study.\n7. Male participants with the potential to father a child must agree to abstain from sperm donation and to use accepted contraceptive regimens from Screening, during the study, and for at least 90 days after end of study.\n8. Participants should agree to refrain from donating blood for at least 30 days after end of study.\n\nExclusion Criteria:\n\nIf an individual meets any of the following criteria, they will be ineligible for this study:\n\n1. History or evidence of clinically significant disorders and deemed not suitable to participants in the study by the Principal Investigator or delegate.\n2. History or presence of any gastrointestinal (GI) disease (except for Gilbert's syndrome or cholecystectomy) or condition that could compromise the participant safety and\u002For absorption of the study drug, including irritable bowel disease, known untreated helicobacter pylori infection, abnormal gastric emptying, dyspepsia, GI ulcers, GI bleeding, or GI surgeries within 6 months before Screening.\n3. Have a known hypersensitivity to any component of the IP formulation or related derivatives of each component.\n4. Have abnormalities in resting vital signs at Screening, on Day -1, or on Day 1 prior to dosing.\n5. History of or ongoing cardiac abnormalities as assessed during Screening, including abnormal and clinically relevant ECG changes, considered by the Investigator.\n6. History of smoking in the past 90 days before Screening which is defined as more than the equivalent of 5 cigarettes weekly (including alternative nicotine products such as cigars, e-cigarettes, chewing tobacco, etc.); and \u002For have a positive urine test for cotinine at Screening or Baseline, or unable to abstain from smoking starting from at least 3 days before Screening, or Day -1 \u002F check-in until end of study.\n7. History of illicit or prescription drug abuse or addiction within 1 year of Screening, or positive urine drug screen at Screening or Baseline. Participants who used a THC \u002F CBD product within 30 days before Screening and added a deterrent from any use before that are excluded.\n8. History of alcohol abuse (unless fully recovered with no use of alcohol within the 12 months prior to Screening), which is defined as exceeding an average weekly intake of 21 standard drinks for males or 14 standard drinks for females (1 standard drink is equivalent to 5 ounces \\[150 mL\\] of wine or 12 ounces \\[360 mL\\] of beer or 1.5 ounces \\[45 mL\\] of hard liquor); or positive alcohol breath test at Screening or Baseline; incapable to refrain from consuming alcohol starting from at least 48 h prior to Day 1 \u002F check-in until end of study.\n9. Has participated in any interventional trial or drug investigation or device investigation (including placebo) within 30 days, or 5 half-lives of the IP, whichever is longer, prior to Screening or has the intention to participate in another trial during the present study.\n10. Have received vaccines within 14 days and within 60 days for live-attenuated vaccines before screening.\n11. Have any medical condition(s) screened by the Investigator and determined to be ineligible or have any acute illness within 7 days prior to Day 1 will be excluded or may be considered for the next cohort if still within their screening window.\n12. Have clinical safety laboratory parameters at Screening (serum chemistry and lipid panel, hematology, coagulation, and urinalysis) that are outside the normal limits and are considered clinically significant in the opinion of the Investigator and the Sponsor's MM (e.g., LFTs \u002F bilirubin ≥ 1.5 ULN and eGFR ≤ 60 ml\u002Fmin\u002F1.73 m2). Participants with elevated unconjugated bilirubin (Gilbert's syndrome) are not excluded.\n13. History of suicidal ideations or suicide attempts, including current instances of either case or any \"yes\" response to C-SSRS at screening.\n14. The participant is pregnant, lactating, or planning to become pregnant within 6 months of being discharged from the trial.\n15. Use of any prescription medicine within 2 weeks, or over the counter (OTC) medicine, herbal remedy, or nutritional supplement, or within 5 half-lives of any drugs, whichever is longer prior to dosing, except for vitamins and occasional use of paracetamol \u002F acetaminophen (≤ 2 g\u002Fday; no more than 3 consecutive days) which will be reviewed by the PI and the Sponsor's MM for determination of acceptability.\n16. Have undergone surgery within 90 days before Screening, or have surgery planned during the study period or within 90 days after the last dose or has previously undergone any surgery that may affect drug absorption, distribution, metabolism, or excretion during the study.\n17. Blood donation or loss of ≥ 450 mL of blood within 90 days before dosing or receiving a blood transfusion within 90 days before dosing. Platelet\u002FPlasma donation is prohibited within 30 days before Screening and until at least 30 days after study completion.\n18. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-1 and HIV-2), or syphilis at Screening.\n19. History of malignancy, with the exception of non-melanoma skin cancer or curatively treated cancer that has not been in full remission for ≥ 5 years, without evidence of recurrence.\n20. Have any special dietary requirements that may include CYP2D6 inhibitors, e.g., grapefruit, bitter citrus products, tonic water, or any other requirement that would prevent compliance with study standardized meals.\n21. History of dysphagia or difficulty swallowing tablets \u002F capsules.\n22. Unable or unwilling to comply with the lifestyle guidelines and evaluations detailed in this protocol, for the duration of the study or have a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.\n23. Participants who cannot perform venous blood sampling (i.e., poor venous access or vasovagal response to injection).\n24. Any other circumstances or laboratory abnormalities that, in the Investigator's judgement, may result in an unacceptable increase in risk to the participant, or impair the participant's ability to participate in and complete the study, or could preclude the evaluation of the participant's response.\n25. Have any clinically significant abnormality on physical examination at Screening, on Day -1, or on Day 1 prior to dosing which in the opinion of the Investigator would exclude them from the study.\n26. History of a severe allergic reaction to any drug or multiple food \u002F drug allergies.\n27. Heavy caffeine drinker (\\> 5 cups or glasses of caffeinated beverages, e.g., coffee, tea, cola per day).\n28. Have any condition which, in the judgement of the Investigator, would prevent the participant from completing the study or complying with study procedures and requirements.",{"count":291,"type":23},64,[92],"The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of NHL907 when administered as multiple oral doses in healthy adult participants.",[29],{"date":277,"type":41},{"date":297,"type":41},"2026-05-12",{"date":299,"type":23},"2027-04",{"name":301,"class":79},"NeuHyll AUS Pty Ltd",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":17,"sex":18,"minAge":20,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":24,"phases":313,"briefSummary":315,"conditions":316,"keywords":319,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":328,"leadSponsor":329,"locationsCount":4},"100643640","early-phase-1-test-retest-trial-with-11cmodag-005-in-pd-or-msa-and-amhc---pilot-phase-100643640","NCT07640542","Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase","An Open-label, Single-center Study to Evaluate the Safety and Test-retest Characteristics of [11C]MODAG-005 as PET Radioligand for Imaging Pathological Alpha-synuclein Deposition in the Brains of Patients With Parkinson's Disease (PD) or Multiple System Atrophy (MSA) Compared to Age-matched Healthy Controls (AMHC) - Pilot Phase","PIOSA","Inclusion Criteria:\n\n* Key inclusion criteria: Patients with MSA fulfilling both the criteria for probable MSA (Gilman et al., 2008) and clinically established MSA (Wenning et al., 2022), patients with PD fulfilling the criteria for clinically established PD (Postuma et al., 2015) or age-matched healthy controls (AMHC).\n\nExclusion Criteria:\n\n1. Laboratory tests with clinically significant abnormalities and\u002For clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2.\n2. Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the trial procedures as judged by the investigator.\n3. Clinically significant renal and hepatic dysfunction as judged by the investigator.\n4. Known hypersensitivity to the active substance or to any of the excipients of \\[11C\\]MODAG-005 solution for injection.\n5. Known hypersensitivity to the active substance or to any of the excipients in anle138b (Emrusolmin) capsules.\n6. Participant has received an investigational drug within 3 months of screening.\n7. Blood donations within 7 days before enrolment.\n8. Pregnant (see 9.1.5) or breast-feeding or having the intention of getting pregnant. Female participants of childbearing potential and male participants with female partners of childbearing potential not willing to practice effective contraception during the trial period and for 90 days following each PET\u002FCT scan.\n9. Unsuitable veins for repeated venipuncture.\n10. Contraindication to blood sampling and\u002For arterial cannulation, including but not limited to allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test on both arms or abnormal coagulation profile at screening. If Allen's test should be \"abnormal\" on both arms, the participant will not be eligible for arterial sampling, but will participate in the remaining assessments.\n11. MRI exclusion criteria include but not limited to: findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct \\>1 cm\\^3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid-Attenuated Inversion Recov ery (FLAIR) sequence that is \\>20 mm in any dimension), infectious disease, space-occupying lesions normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease. Findings that are expected to be present in the PD and MSA participants (e.g. absence of swallow tail sign, presence of regional atrophy or hot cross bun sign) do not lead to exclusion of these participants.\n12. Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.\n13. Unwilling and\u002For unable to cooperate with trial procedures.\n\n    Exclusion criteria for age-matched healthy controls:\n14. Relevant hepatic parameters above upper limit of normal (ULN), i.e., glutamic pyruvic transaminase (GPT), glutamic oxaloacetic transaminase (GOT), bilirubin\n15. Relevant renal parameters outside normal limits, i.e., serum creatinine and blood urea nitrogen (BUN) above ULN; urinary albumin-creatinine ratio (uACR) below lower limit of normal (LLN)\n16. Systolic blood pressure \\\u003C90 or \\>140 mmHg; diastolic blood pressure \\\u003C45 or \\>90 mmHg; heart rate \\\u003C50 or \\>95 beats per minute (BPM)","75 Years",{"count":312,"type":23},9,[314],"EARLY_PHASE1","This is an open-label, single-center Phase 1 study evaluating the safety, tolerability, and test-retest characteristics of \\[11C\\]MODAG-005, an investigational positron emission tomography\u002Fcomputed tomography (PET\u002FCT) radioligand intended to image pathological alpha-synuclein deposition in the brain. The study will enroll participants with Parkinson's disease (PD), participants with multiple system atrophy (MSA), and age-matched healthy controls (AMHC).\n\nParticipants with PD or MSA will undergo two \\[11C\\]MODAG-005 PET\u002FCT imaging sessions: one baseline scan and one follow-up scan 7 to 48 days later. Age-matched healthy controls will undergo one baseline scan. A subset of PD and MSA participants will receive a single oral dose of anle138b (Emrusolmin) before the second scan to evaluate tracer uptake under blocking conditions. The primary objective is to assess the safety and tolerability of \\[11C\\]MODAG-005. Secondary objectives include evaluating whether \\[11C\\]MODAG-005 PET imaging can distinguish participants with MSA or PD from age-matched healthy controls, distinguish PD from MSA, and determine test-retest variability of PET outcome measures.",[317,318,29],"Parkinson Disease (PD)","MSA - Multiple System Atrophy",[320,321,322,323,324],"MODAG","MODAG GmbH","Synuclein","Neurodegeneration","Lewy Body","2026-06-06",{"date":277,"type":41},{"date":134,"type":23},{"date":230,"type":23},{"name":321,"class":79},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":17,"sex":18,"minAge":88,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":24,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":348,"leadSponsor":350,"locationsCount":49},"100643769","alcohol-sensitivity-among-older-adults-who-consume-alcohol-100643769","NCT07636447","Alcohol Sensitivity Among Older Adults Who Consume Alcohol","Individual Differences in Alcohol Sensitivity","Inclusion Criteria\n\n* Alcohol Drinkers who consume alcohol on a regular basis\n* No history of significant substance misuse\n* at least 12 years of education or GED equivalence Exclusion Criteria\n* current Cigarette smoker\n* Type 1 Diabetes or uncontrolled Type 2 Diabetes\n* Epilepsy\n* Neurodegenerative disorder\n* Significant psychiatric disorder such as a psychotic disorder, bipolar disorder, current major depression or PTSD","80 Years",{"count":339,"type":23},80,[26],"This is a proof-of-concept study exploring individual differences in sensitivity to alcohol among older healthy current drinkers aged 65 to 80. Participants will complete two sessions during which they will complete questionnaires and laboratory measures of mental abilities and brain activity and receive a beverage that may or may not contain a moderate dose of alcohol.",[29],[344],"Older adults, alcohol drinkers, cognition","2026-06-03",{"date":225,"type":41},{"date":40,"type":23},{"date":349,"type":23},"2028-06",{"name":351,"class":48},"University of Florida",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":123,"enrollmentInfo":359,"targetDuration":4,"studyType":24,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":252},"100643467","phase-1-a-trial-to-compare-the-pharmacokinetics-of-two-presentations-of-navenibart-in-healthy-participants-100643467","NCT07635095","A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants","A Phase 1, Randomized, Open-Label, Parallel-Group Trial Comparing the Pharmacokinetics of Navenibart Administered by Vial\u002FSyringe Versus Autoinjector in Healthy Adult Volunteers","Key Inclusion Criteria:\n\n* Males and females 18 to 55 years of age\n* In good health, as determined by the Investigator\n* Written informed consent, including confirmation of willingness to comply with all trial procedures\n* Body weight between 50 and 100 kg, and body mass index (BMI) between 18 and 30 kg\u002Fm\\^2\n* Has not previously received navenibart\n* Not pregnant or breastfeeding and agreement to comply with requirements for pregnancy and breastfeeding, contraception use, and egg donation for the specified periods.\n\nKey Exclusion Criteria:\n\n* Prior or ongoing medical history, or results of a medical assessment, that the Investigator feels could result in a risk to the safety of the participant or the quality of data from the trial.\n* Key laboratory results outside of defined ranges\n* History or positive test results for tobacco, nicotine products, alcohol, marijuana (cannabis), or drugs of abuse\n* Receipt of other prohibited medications, biologic medications, or investigational products within defined windows prior to dosing\n* History of severe allergic reactions with an unknown cause\n* Donation of blood (at least 500 mL), or any amount of platelets or plasma within defined windows prior to dosing.\n* Known hypersensitivity to any component of navenibart\n* Any condition that the Investigator feels may affect the ability to provide written informed consent or demonstrates unwillingness or inability to comply with trial procedures",{"count":360,"type":23},180,[92],"The goal of this clinical trial is to compare two different presentations (vial and syringe versus autoinjector) of navenibart in healthy adult volunteers. The main questions it aims to answer are:\n\n* Do these presentations lead to similar drug concentrations in the blood?\n* Do these presentations lead to similar safety and tolerability?\n\nResearchers will compare the drug concentrations and safety profile of each group to determine if they are similar.\n\nParticipants will:\n\n* Receive one dose of navenibart with either the vial and syringe or the autoinjector.\n* Stay in the clinic beginning one day prior to dosing through 2 days after dosing.\n* Return to the clinic for approximately 9 additional non-residential visits.\n* Complete medical and other testing, including blood draws.",[29],[365,366],"Navenibart","STAR-0215",{"date":225,"type":41},{"date":369,"type":41},"2026-04-21",{"date":371,"type":23},"2026-12",{"name":373,"class":79},"Astria Therapeutics, Inc.",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":123,"enrollmentInfo":381,"targetDuration":4,"studyType":24,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":397,"locationsCount":49},"100643592","the-effect-of-tavns-and-upper-gi-motility-100643592","NCT07632378","The Effect of taVNS and Upper GI Motility","The Effect of Non-invasive Transauricular Vagus Nerve Stimulation on Upper Gastrointestinal Motility in Healthy Individuals","Inclusion Criteria:\n\n* Healthy participants (defined as those without a pre-existing medical comorbidity, including those without a history of cardiac arrhythmia).\n* Age between 18 and 55 years.\n* Ability to understand and speak the Dutch language.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Use of any substances (such as medication or recreational drugs) influencing gastrointestinal motility\n* Not meeting the inclusion criteria above.\n* Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional of hierarchical position with regards to any of the study team members or their department.",{"count":382,"type":23},12,[26],"This single-center randomized controlled cross-over trial aims to investigate the effect of transcutaneous auricular vagus nerve stimulation on upper gastrointestinal motility in healthy individuals.\n\nThe primary aim of this study is to assess the impact of tVNS on gut motor function, with regards to its potential to induce phase III contractions in the upper GI tract.\n\nSecondary objectives include:\n\n* To study the effect of tVNS on other parameters characterizing upper GI motility such as the number of duodenal phase III contractions, gastric and duodenal phase MMCs, amplitude of antral contractions and motility index\n* To study the effect of tVNS on plasma levels of motilin and PP\n* To evaluate the effect of tVNS on parameters related to autonomic outflow, using a Shimmer3 GSR Sensor for heart rate variability and skin conductance.\n* To compare the results of the measurements of antroduodenal manometry with measurements of Gastric Alimetry\n\nParticipants will undergo tVNS (applied to the cymba conchae of the left ear) alternating with sham stimulation (using a non-conducting electrode) in a blinded, pre-randomized fashion, using two 4-hour blocks during an 8-hour fasted antroduodenal manometry recording period. Optionally, participants may simultaneously also undergo body surface gastric mapping using the Gastric Alimetry system.",[29],[387,388,389,390,391],"Vagal Nerve Stimulation","Upper GI motility","Randomised Controlled Trial","Antroduodenal Manometry","Gastric Alimetry","2026-06-02",{"date":247,"type":41},{"date":395,"type":41},"2025-02-25",{"date":134,"type":23},{"name":398,"class":48},"Daniel Keszthelyi",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":406,"targetDuration":4,"studyType":24,"phases":408,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":49},"100643838","exploring-the-role-of-tavns-in-nausea-management-100643838","NCT07632456","Exploring the Role of taVNS in Nausea Management","Exploring the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Alleviating Nausea in Healthy Adults: a Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Healthy participants (defined as those without a pre-existing medical comorbidity).\n* Aged between 18-65 years.\n* Ability to understand and speak the Dutch language.\n* BMI between 18 and 25 kg\u002Fm2\n\nExclusion Criteria:\n\n* Medical history of chronic or severe diseases affecting the cardiovascular, respiratory, urogenital, gastrointestinal\u002Fhepatic, haematologic\u002Fimmunologic, HEENT (head, ears, eyes, nose, throat), dermatological\u002Fconnective tissue, musculoskeletal, metabolic\u002Fnutritional, endocrine, neurological\u002Fpsychiatric systems.\n* A history of major abdominal surgery.\n* Gastrointestinal complaints.\n* Any use of medication, especially those affecting gastric motility and nausea, apart from oral contraceptives.\n* Current or lifetime psychopathology (including PHQ-9 and GAD-7 scores \\> 10)\n* Substance abuse, including excessive alcohol consumption (\\>20 alcoholic consumptions per week) and the use of recreational drugs.\n* Smoking.\n* Pregnancy, lactation, or intention to become pregnant during the study period\n* Use of devices (e.g., cochlear implants) or other conditions (e.g. wounds, permanent ear-piercing) complicating the use of the tVNS device.\n* Administration of investigational drugs or participation in any scientific intervention study that might interfere with this study (to be determined by the principal investigator) within 180 days preceding the commencement of the study.\n* Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department.",{"count":407,"type":23},35,[26],"This single-center randomized controlled trial aims to investigate the efficacy of transcutaneous auricular vagus nerve stimulation in alleviating nausea in healthy adults.\n\nThe primary aim of this study is to assess the efficacy of taVNS in reducing nausea in healthy adults subjected to nausea induction through intragastric lipid infusion, compared to sham stimulation, as measured by 0-100 Visual Analogue Scale (VAS) scores.\n\nThe secondary objectives include evaluating the potential of taVNS to alleviate other gastrointestinal symptoms, such as abdominal pain, bloating, and fullness, as well as exploring its effects on the desire to eat, all measured using 0-100 VAS scores. Additionally, changes in autonomic parameters, plasma levels of ghrelin and motilin, and salivary cortisol will be evaluated. The relationship between the nausea response and affective symptoms, as well as personality traits, will also be explored.\n\nParticipants will be randomly assigned to either the taVNS or the sham stimulation group, with the intervention administered for 30 minutes immediately following nausea induction through intragastric lipid infusion.",[29],[387,412,389],"Nausea",{"date":247,"type":41},{"date":415,"type":41},"2025-12-08",{"date":417,"type":23},"2026-09",{"name":398,"class":48},{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":337,"enrollmentInfo":426,"targetDuration":427,"studyType":178,"phases":4,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":49},"100639419","stanford-university-microbiome-bank-100639419","NCT07625059","Stanford University Microbiome Bank","SUMB","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Any person aged 18-80 years of age, inclusive at the time of signing the consent\n* In good general health as evidenced by medical history\n* Ability to travel to donation facility on a weekly basis\n* Residence within 5 miles of Stanford Campus\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation\n* Capable of providing signed informed consent.\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Enteric infections\n* Previous infection with Clostridium difficile\n* History of gastrointestinal surgery: Participants with gastrointestinal surgeries below the pylorus will be excluded from this protocol, including participants with a history of colectomy, segmental colonic resection, and small bowel resections.\n* Documented severe gastroparesis\n* Active intestinal obstruction\n* Dysphagia (oropharyngeal, esophageal, functional or neuromuscular)\n* History or current malignancy diagnosis\n* History of recurrent aspiration episodes\n* Any conditions associated with a high risk of bleeding, including but not limited to coagulopathy\u002Fbleeding disorder, severe liver disease, active or recent GI bleeding, or recent abdominal or other GI surgery\n* Active diagnosis of major depressive disorder\n* Active diagnosis of major anxiety disorder\n* Severe immunodeficiency, inherited or acquired (e.g., Human immunodeficiency virus, active chemotherapy or immunosuppressive medications \\[including steroids, biologic therapy, or bone marrow suppressive agents\\], or radiation therapy)\n* BMI of less than 18 or BMI greater than 30\n* Record of eating disorders\n* Active use of GLP-1 inhibitors\n* Diagnosis of Human immunodeficiency virus infection; Hepatitis A, B, C \\& E; Epstein Bar Virus; parasitic infections; Syphilis\n* Pregnancy \\& lactation\n* Active drug, or alcohol use disorder\n* Tobacco, marijuana and e-cigarette use\n* Any other significant medical condition that could confound or interfere with evaluation of safety or tolerability or prevent compliance with the study protocol at the discretion of the Investigator\n\nPrior\u002Fconcomitant therapy\n\n* Active antibiotic use\n* Active treatment with high levels of immunosuppressive therapies (active chemotherapy or immunosuppressive medications \\[including steroids, biologic therapy, or bone marrow suppressive agent\\], or radiation therapy)\n* Simultaneous participation in another interventional clinical trial\n\nOther exclusion criteria\n\n-Inability to comply with research requirements",{"count":5,"type":23},"1 Year","This protocol establishes a centralized stool donor bank and research platform to support microbiota transplantation therapy (MTT) for microbiota-mediated diseases. The study will characterize donor microbiome, metabolite, immune, and dietary profiles.",[29],"2026-06-01",{"date":432,"type":41},"2026-06-04",{"date":434,"type":23},"2026-08-01",{"date":436,"type":23},"2027-08-01",{"name":438,"class":48},"Sean Spencer",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":310,"enrollmentInfo":447,"targetDuration":4,"studyType":24,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":49},"100639901","exploration-of-potential-biomarkers-of-polyphenol-intake-from-artichoke-by-product-supplements-100639901","NCT07615673","Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements","Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids","ARTI-UP ADME","Inclusion Criteria:\n\n* Men and women between 18 and 75 years of age.\n* Normal-weight volunteers (BMI of 18.5-24.9 kg\u002Fm²).\n* Subjects must be able to understand and willing to sign the informed consent form, and must comply with all study procedures and requirements.\n\nExclusion Criteria:\n\n* Presence of chronic gastrointestinal pathology.\n* Lactating or pregnant women, or those planning to become pregnant.\n* Individuals who have taken antibiotics within the 3 months prior to the study.\n* Individuals currently taking supplements (plant-derived, fiber, or probiotics) unless they are willing to discontinue use during the 4-day study intervention and ensure a minimum washout period of 14 days prior to baseline measurements.\n* Individuals with an alcohol intake \\> 80 g\u002Fday.\n* Presence of allergy or intolerance to artichoke.\n* Individuals undergoing treatment with anticoagulants, immunosuppressants, or cytotoxic agents.\n* Presence of renal or hepatic failure.\n* Presence of immunodeficiency or being HIV positive.\n* Subjects with any type of cancer, those undergoing cancer treatment, or those for whom at least 5 years have not passed since remission.\n* Presence of weight loss greater than 5% in the 6 months prior to the trial.\n* Lack of time or geographical availability to attend the study visits.\n* Failure to sign the informed consent form.\n* Difficulty in undergoing blood extraction\u002Fcollection.\n* Having donated blood within 14 days prior to the baseline visit.\n* Individuals who demonstrate difficulty swallowing capsules, tablets, pills, or similar.",{"count":448,"type":23},16,[26],"The bioavailability study analyzes the absorption, distribution, metabolism, and excretion (ADME) processes of the polyphenols under study (HCAs). To achieve the planned objectives, blood and urine samples will be collected before and at different time intervals following the intake of the study supplement, which will consist of capsules made from dehydrated artichoke by-products rich in HCAs.\n\nTo determine the bioavailability of the active compounds, volunteers will be asked to follow a diet low in polyphenols\u002Fplant-based foods for 48 hours prior to the supplement intake and up to 48 hours after product consumption. Blood and urine samples will be collected before intake and during the following 48 hours. Subsequently, the samples will be analyzed using high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS) to identify and quantify the bioactive compounds of interest and their metabolites. The results of the ADME trial will allow for the identification of plasma and urinary metabolites, the characterization of intake markers, and the determination of inter-individual differences in metabolic profiles.",[29,452,453,454],"ADME","Polyphenols Absorption Profile","Polyphenolic Compounds and Metabolism",{"date":345,"type":41},{"date":457,"type":41},"2026-05-26",{"date":38,"type":23},{"name":460,"class":48},"Iziar Amaia Ludwig Sanz Orrio",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":17,"sex":18,"minAge":468,"maxAge":469,"enrollmentInfo":470,"targetDuration":472,"studyType":178,"phases":4,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":4},"100637772","multilevel-exercise-response-in-rowers-100637772","NCT07613619","Multilevel Exercise Response in Rowers","Multilevel Assessment of Physiological, Molecular, Metabolic, Intestinal, and Psychophysiological Responses to Rowing Ergometer Exercise in Competitive Rowers","Inclusion Criteria:\n\n* Male and female members of the Polish Youth National Rowing Team.\n* Age between 19 and 24 years.\n* Regular participation in structured rowing training.\n* Medical clearance for participation in maximal exercise testing.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Lack of consent for blood sampling or study participation.\n* Current injury or health condition contraindicating maximal exercise.\n* Acute infection, fever, or inflammatory condition at the time of testing.\n* Use of anti-inflammatory medications.\n* Use of performance-enhancing substances.\n* Use of dietary supplements within 3 months before study participation.\n* Any medical contraindications identified by the study physician.","19 Years","24 Years",{"count":471,"type":23},30,"6 Months","This observational study aims to evaluate multilevel physiological, molecular, metabolic, intestinal, immunological, and psychophysiological responses to rowing-specific exercise in elite rowers. The study is designed to investigate how maximal and prolonged rowing ergometer exercise influences integrated adaptive mechanisms related to mitochondrial function, metabolic regulation, intestinal permeability, immune activation, DNA damage response, and psychological status.\n\nThirty members of the Polish Youth National Rowing Team, aged 19-24 years, will participate in the study during two different training periods. During the competitive phase, participants will perform a 2000-m maximal rowing ergometer test, whereas during the preparatory phase they will complete a 6000-m rowing ergometer test. Blood samples and physiological measurements will be collected before exercise, immediately after exercise, and after 1 hour of recovery.\n\nThe study will assess gene expression, circulating biomarkers, flow cytometry parameters, blood morphology, lactate concentration, continuous glucose monitoring data, wearable metabolic sensor measurements, nutritional status, and psychological responses. The primary objective is to identify integrated biomarkers reflecting exercise load, recovery dynamics, and adaptive capacity in highly trained athletes. The study also aims to improve understanding of the interaction between metabolic, mitochondrial, intestinal, immunological, and psychophysiological responses to intensive exercise in rowing.",[29],[476,477,478,479,480,481,482],"Rowing","Exercise physiology","Mitochondrial function","Intestinal permeability","DNA damage response","Psychophysiology","Elite athletes","2026-05-21",{"date":485,"type":41},"2026-05-29",{"date":487,"type":23},"2026-05-17",{"date":489,"type":23},"2027-01-30",{"name":491,"class":48},"Poznan University of Physical Education",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":24,"phases":501,"briefSummary":502,"conditions":503,"keywords":507,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":252},"100577854","metabolome-and-gut-microbiome-changes-during-smoking-cessation-in-long-term-drug-therapy-in-a-therapeutic-community-100577854","NCT06803706","Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community","Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* diagnosis of a form of substance use disorder (F1x.x) by a licensed psychiatrist according to ICD-10\n* minimum age of 18 years\n* sufficient knowledge of the German language\n* willingness to quit smoking\n* willingness and ability to consent\n\nInclusion criteria for healthy controls :\n\n* minimum age of 18 years\n* sufficient knowledge of the German language\n* willingness and ability to consent\n\nExclusion Criteria:\n\n* lack of consent, inability to provide informed consent\n* age below 18,\n* acute psychotic symptoms or acute suicidal tendencies\n* cardiovascular disease\n* pregnancy or breastfeeding\n* severe mental or organic illnesses (such as epilepsy, brain tumors, recent major surgery), tumor diseases, dementia (Mini Mental Score \\\u003C20), severe autoimmune diseases or immunosuppression, acute infections, or acute diarrhea, prior gastrointestinal surgery (except appendectomy)\n* probiotic intake within the last 6 months,\n* ongoing consumtion of dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study\n* prior participation in a smoking cessation programme",{"count":500,"type":23},150,[26],"Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction.\n\nObjectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems.\n\nMethods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up.\n\nA cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.",[504,505,506,29],"Substance Use Disorder (SUD)","Alcohol Use Disorder (AUD)","Nicotine Addiction",[508,509,510,511,512],"Metabolomics","Gut microbiome","Substance use disorder","nicotine addiction","smoking cessation","2026-05-15",{"date":515,"type":41},"2026-05-18",{"date":517,"type":41},"2025-05-05",{"date":519,"type":23},"2026-10-28",{"name":521,"class":48},"Sigmund Freud PrivatUniversitat",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":528,"targetDuration":4,"studyType":24,"phases":529,"briefSummary":530,"conditions":531,"keywords":532,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":49},"100639418","overcoming-the-barriers-to-effective-transcranial-temporal-interference-stimulation-in-humans-100639418","NCT07593859","Overcoming the Barriers to Effective Transcranial Temporal Interference Stimulation in Humans","Inclusion Criteria:\n\n* Free of neurological or orthopedic conditions that may impact the ability to participate.\n* Right-hand dominant (self-reported)\n* Aged 18-65 years\n\nExclusion Criteria:\n\n* Ferromagnetic metal implants in the brain\u002Fskull or elsewhere (dental implants excluded).\n* Any implanted electronic device (e.g. cardiac pacemaker, cochlear implant, deep brain stimulator, medication infusion pump; vagal nerve stimulator)\n* Diseased or damaged skin on face or scalp\n* History of migraines, fainting, seizures\u002Fepilepsy, or psychiatric illness\n* Neurological disorder or intracranial lesion\n* Frequent or severe headaches\n* Prior adverse reaction to transcranial magnetic stimulation\n* Currently pregnant\n* Suspected or diagnosed heart problems (e.g. arrhythmia, cardiac disturbances).\n* Insulin-dependent diabetes\n* Suspected or diagnosed epilepsy or a familial history of epilepsy\n* Use of alcohol or recreational drugs in the prior 12 hours\n* Use of prescription and over the counter medications will be grounds for exclusion except for: contraceptive (birth control) drugs (e.g. those containing ethinyl estradiol and\u002For norethindrone), and seasonal allergy medications (e.g. cetirizine (Zyrtec), fexofenadine (Allegra), and loratadine (Claritin)).",{"count":471,"type":23},[26],"Transcranial temporal interference stimulation (TIS) is an emerging novel tool for non-invasive transcranial brain stimulation that holds the potential for focal and steerable neuromodulation, and the possibility to stimulate focally at depth. TIS involves combining two high frequency waveforms to create a waveform with a \"beat\" frequency that is physiological relevant for neuromodulation. Successful applications to deep brain targets as well as steerability of the stimulation focus have been demonstrated in mice. Numerous recent investigations in humans have shown great clinical potential for this technology, however several questions about the basic mechanism of TIS action remain. The investigators will apply TIS to the motor cortex of humans and use established transcranial magnetic stimulation techniques to assess cortical excitability in relation to the phase of the TIS waveform. Using TMS, the investigators will i) validate that effects of TIS are due to the \"beat\" frequency and not the high frequency carrier signal, ii) evaluate the effect of the TIS carrier frequency, and iii) evaluate that whether changes in corticospinal excitability outlast the period of stimulation. Knowledge gained from this experiment will provide a basis for the future use of TIS for clinical applications, including informing parameter optimization.",[29],[533],"transcranial temporal interference stimulation","2026-05-14",{"date":515,"type":41},{"date":537,"type":41},"2026-02-01",{"date":539,"type":23},"2029-10-01",{"name":541,"class":48},"Northeastern University",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":24,"phases":551,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":567,"locationsCount":569},"100637585","rem-enhancement-sleep-technology-for-well-being-emotion-and-life-lift-100637585","NCT07589114","REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift","RESTWELL","Inclusion Criteria:\n\n* age at least 18;\n* the ability to provide consent;\n* the absence of neurocognitive and severe psychiatric disorders.\n\nExclusion Criteria:\n\n* the presence of severe cognitive impairment;\n* the presence of psychosis;\n* inability to understand the informed consent and complete questionnaires.",{"count":550,"type":23},360,[26],"This study aims to explore the efficiency of a digital, Smartphone-delivered intervention for improving the quality of REM sleep on the mental health, emotion regulation and overall life quality of users.",[29],[555,268,556,557,558,559,560,561],"digital intervention","emotion regulation","well-being","quality of life","mental health","technology","REM sleep","2026-05-09",{"date":513,"type":41},{"date":565,"type":41},"2025-11-15",{"date":76,"type":23},{"name":568,"class":48},"George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures",2,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":17,"sex":18,"minAge":87,"maxAge":57,"enrollmentInfo":578,"targetDuration":4,"studyType":24,"phases":579,"briefSummary":580,"conditions":581,"keywords":585,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":49},"100637977","acute-effects-of-jgermeister-with-energy-drinks-jgermbomb-100637977","NCT07588022","Acute Effects of Jägermeister With Energy Drinks (Jägermbomb)","Acute Effects of an Explosive Cocktail With Energy Drinks That is Trendy Among Young People, the Jägerbomb","JB","Inclusion Criteria:\n\n1. Men and women between 18-45 years old with a weight between 50-90 kg for men and between 55-80 kg for women, and a body mass index (BMI) between 19-28 kg\u002Fm2. Lower or higher weights or BMIs are allowed, in the opinion of the Principal Investigator or the collaborators designated by the Principal Investigator and that do not pose a risk to the subjects and do not interfere with the objectives of the study.\n2. Alcohol consumption in the form of occasional binge drinking (≥1 time\u002Fmonth), social alcohol consumption (≥10g\u002Fday distributed weekly) and experience in alcohol intoxication.\n3. Consumption ≥7 drinks with methylxanthines (coffee, tea, chocolate, cola, BE) per week and who have consumed ED on at least one occasion.\n4. Understand and agree to the trial procedures and sign an informed consent.\n5. History and physical examination that demonstrate no organic or psychiatric disorders.\n6. The ECG and general blood and urine tests performed before the test should be within normal limits. Minor or punctual variations from the limits of normality are allowed if, at the discretion of the Principal Investigator, taking into account the state of science, they are not of clinical significance, do not pose a risk to the subjects and do not interfere with the assessment of the product. These variations and their non-relevance will be justified in writing in a specific way.\n\nExclusion Criteria:\n\n1. Not meeting the inclusion criteria.\n2. History or clinical evidence of gastrointestinal, liver, renal or other disorders that may involve an alteration in the absorption, distribution, metabolism or excretion of the drug, or that are suggestive of gastrointestinal irritation by drugs.\n3. Current history of substance use disorder according to DSM-V (except nicotine). A previous history of mild substance use disorder (corresponding to substance abuse according to DSM-IV criteria) is admitted.\n4. History or clinical evidence of psychiatric disorders, alcoholism, abuse of drugs or other drugs or habitual consumption of psychoactive drugs.\n5. Have participated in clinical trials with drugs or nutraceuticals in the previous 12 weeks.\n\n5\\) Have suffered any organic disease or major surgery in the three months prior to the start of the study.\n\n6\\) Subjects who have an intolerance or have had serious adverse reactions to alcohol. The inclusion of subjects of oriental origin who do not have an intolerance to alcohol will be allowed.\n\n7\\) Have taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies, or dietary supplements that, in the judgment of the Principal Investigator or collaborators designated by the Principal Investigator, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to study sessions will not be grounds for exclusion if it is assumed to have been completely eliminated on the day of the experimental session.\n\n8\\) Smokers of \\>5 cigarettes a day. 9) Consumption of more than 20 g of alcohol daily in women and more than 40 g in men.\n\n10\\) Consumers of more than 5 coffees, teas, colas, or other stimulant or xanthine beverages daily in the 3 months prior to the start of the study.\n\n11\\) Subjects who are not able to understand the nature of the trial and the procedures they are asked to follow.\n\n12\\) Subjects with positive serology for hepatitis B, C or HIV. 13) Women who are pregnant or breastfeeding, or who use hormonal contraceptives or do not use reliable contraceptive measures during the study (such as abstinence, intrauterine devices, barrier methods or with a vasectomized partner).\n\n14\\) Women with amenorrhea or premenstrual syndrome of severe intensity.",{"count":262,"type":23},[26],"The main objective of this study is to compare the acute effects of drinking Jägerbombs with drinking alcohol alone during a binge-drinking episode, which involves consuming a large amount of alcohol in a short period of time to become intoxicated. Secondary objectives are to assess whether Jägerbombs produce prototypical alcohol effects, increase stimulation and rewarding effects, affect coordination, time reaction and vision, change stress-related hormone responses, and cause hangover symptoms.",[582,29,583,584],"Alcohol Drinking","Binge Alcohol Consumption","Energy Drinks",[586,587,588,589],"Binge drinking","Jägerbomb","Alcohol","Psychomotor performance","2026-05-08",{"date":534,"type":41},{"date":593,"type":41},"2026-02-18",{"date":595,"type":23},"2027-06",{"name":597,"class":48},"Fundació Institut Germans Trias i Pujol",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":24,"phases":606,"briefSummary":607,"conditions":608,"keywords":609,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":620,"locationsCount":49},"100639813","mystical-experiences-without-psychedelics-and-how-integration-improves-well-being-in-adults-100639813","NCT07584070","Mystical Experiences Without Psychedelics and How Integration Improves Well-Being in Adults","Mystical Experiences Without Psychedelics: The Nature of Peak Spiritual Experiences and How Integration Leads to Human Flourishing","Inclusion Criteria:\n\n* age 18 years or older;\n* active Christian faith;\n* willing to experience hypnosis;\n* English-speaking; able to complete one in-person session and 1- and 2-month follow-up assessments.\n\nExclusion Criteria:\n\n* prior psychedelic use;\n* severe mental illness (e.g., schizophrenia, bipolar disorder, psychosis, borderline personality disorder);\n* unwillingness to experience hypnosis;\n* inability to complete study procedures",{"count":148,"type":23},[26],"The goal of this clinical trial is to evaluate whether a guided, non-drug spiritual intervention can facilitate mystical-type experiences and improve well-being in Christian adults.\n\nThe main questions it aims to answer are:\n\n* Does the guided spiritual intervention produce measurable mystical experiences?\n* Does participation in the intervention and assigned integration program lead to improvements in well-being over time?\n\nResearchers will compare a Christian-based integration program to a structured control integration program to determine whether Christian-based integration leads to greater improvements in well-being.\n\nParticipants will:\n\n* Complete baseline questionnaires assessing spiritual experiences, religiosity, and well-being\n* Complete one in-person session of the \"guided invocation for mystical experience\"\n* Be randomly assigned to complete either a Christian-based or control integration program for 4 weeks\n* Complete follow-up assessments at 1 month and 2 months",[29],[610,611,612,613],"mystical experience","peak spiritual experience","integration","hypnosis","2026-05-07",{"date":616,"type":41},"2026-05-13",{"date":618,"type":23},"2026-04",{"date":436,"type":23},{"name":621,"class":48},"Baylor University",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":17,"sex":18,"minAge":260,"maxAge":88,"enrollmentInfo":630,"targetDuration":4,"studyType":24,"phases":632,"briefSummary":633,"conditions":634,"keywords":637,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":4},"100638239","dora---a-study-using-digital-health-toolsplatform-to-explore-the-impact-of-the-consumption-of-senior-milk-powder-containing-synbiotics-on-the-gut-microbiome-in-healthy-aging-individuals-100638239","NCT07575529","DORA - A Study Using Digital Health Tools\u002FPlatform to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals","DORA - An Exploratory, Interventional Study Using Digital Health Tools and OneBiome to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals","DORA","Inclusion Criteria:\n\n1. Participants aged between 40 to 65 years (bounds included)\n2. Participants who are community-living\n3. Participants who are in good health (self-reported)\n4. Participants own and are willing to use their personal non-shared mobile device (iPhone 8 or later, with iOS version 16 or later), to pair with the study-provided Apple Watch SE, for the duration of the study\n5. Participant should be able to use mobile applications on smartphones to perform tasks in the study, have access to the internet and a smartphone or tablet to take and upload images and\u002For videos of stool, and other anatomical sites\n6. Participant should be able to comprehend the content of the study and to complete the study questionnaires in English\n7. Written and signed consent from participant\n8. Currently reside in Singapore and with the intention to reside in Singapore for at least the duration of the study.\n\nNote: Clinical trial participants may be permitted to undertake short-duration travel not exceeding 72 consecutive hours each time, provided such travel does not conflict with scheduled study visits, investigational product administration, or protocol-defined assessments. Prior notification to principal investigator or designated study personnel is required. The participant must be instructed on potential risks, adverse event reporting during the travel period.\n\nExclusion Criteria:\n\n1. Pregnant or lactating, or wish to become pregnant during the period of the study (self-reported)\n2. Participant with current or intended participation in a clinical study involving investigational or marketed products\n3. Use of named prebiotics, probiotics or synbiotics (in a capsule or sachet) within the last 4 weeks prior to screening or are planning to use it during the study including but not limited to the products listed below:\n\n   * BioGaia Probiotic Tablets\n   * LACTO FIT Probiotics\n   * Nano Singapore Digestive Wellness Formula\n   * California Gold Nutrition LactoBif Probiotics\n   * Life Space Probiotic\n   * Vivomixx 112.5 Billion Live Probiotics\n   * Duolac Daily Vitality Probiotic\n   * ATOMY Probiotics 10+\n   * Blackmores Ultra Max Probiotics+\n   * Holistic Way High Strength Probiotic 75 Billion\n4. Use of any commercial healthy aging milk powder within the last 4 weeks prior to screening or are planning to use it during the study including but not limited to:\n\n   * Boost Optimum\n   * Enercal complete\n   * Anlene\n   * Ensure\n5. Use of systemic antibiotics within the last 8 weeks prior to screening\n6. Known allergy or intolerance to Galactooligosaccharides (GOS), lactose, probiotics, or any ingredient in the SP\n7. Gastrointestinal (GI) surgery within the last 6 months prior to screening\n8. BMI below 18.5 kg\u002Fm² or above 27.5 kg\u002Fm²\n9. Participants who are using insulin, or have poorly controlled diabetes (HbA1c ≥ 10%) within last 3 months prior to screening\n10. Other severe disease(s) impairing activities of daily living or affecting the ability to complete the study assessments such as malignancy, end stage organ failure, COPD on long-term oxygen therapy, stroke with significantly residual functional weakness, cardiac failure with poor effort tolerance, significant neurological disease such as cognitive impairment from dementia, severe neuromuscular disease like Parkinson's disease, psychiatric disease\u002Fdisorder, auto-immune disease, allergic conditions requiring chronic systemic medication, other severe GI disease(s) such as Crohn's disease, GI cancer, or ulcerative colitis diagnosed by a physician\n11. History of drug abuse (Drug Abuse Screening Test (DAST) score of \\>2) or alcohol abuse (Alcohol Use Disorders Identification Test (AUDIT) score of \\> 7) within the last 6 months prior to screening\n12. Participants on a special diet, e.g., vegan, low-carbohydrate for intentional weight loss, ketogenic, low-FODMAP diet at the screening visit, or plan for such diet during the study duration\n13. Employees and\u002For children\u002Ffamily members or relatives of employees of Danone or the study team members (dependent relationship with study team members) participating sites such as, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention\n14. Participant expected to be living in the same home as a current participating participant and to concomitantly receive SP",{"count":631,"type":23},100,[26],"The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital health parameters in community-living adults in good health.\n\nThe study enrolls adults aged 40 to 65 years and aims to investigate changes in gut microbial composition, with a primary focus on butyrate-producing microbial taxa, following at least 28 days of study product consumption. Secondary and exploratory objectives include assessment of stool metabolites, blood-based biomarkers, bowel patterns, sleep quality, physical activity, cognitive function, dietary patterns, and quality of life.\n\nApproximately 125 participants will be recruited in Singapore to achieve 100 study completers. Following informed consent and screening, participants undergo a baseline observation period of 14 days during which physiological and lifestyle data are collected using wearable digital health devices. Baseline assessments also include blood sampling, stool collection for microbiome analysis, digital imaging and videography, and completion of validated questionnaires.\n\nAfter completion of baseline assessments and collection of the first stool sample, participants initiate consumption of the study product, a senior milk powder containing a defined synbiotic formulation. The study product is consumed twice daily for a minimum of 28 days and up to 35 days to allow completion of study assessments.\n\nParticipants return for end-of-intervention assessments following the study product phase, including repeat biological sampling, physical and digital assessments, and questionnaires. Stool microbiome profiles and other exploratory outcomes are compared between baseline and post-intervention time points.\n\nThis exploratory study is intended to generate feasibility data and hypotheses regarding the effects of synbiotic nutritional intervention and the integration of biological and digital health data in the context of healthy aging.",[29,635,636],"Gut Microbiomes","AI",[65,638,639,640,641,642,643,644,645],"Gut Microbiome","Gut Health","Probiotics","Prebiotics","Nutritional Intervention","Microbiome Profiling","Digital Health","Wearable Devices",{"date":297,"type":41},{"date":648,"type":23},"2026-04-27",{"date":650,"type":23},"2027-03-31",{"name":652,"class":79},"Danone Asia Pacific Holdings Pte, Ltd."]