[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-health\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-health":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,44,72,105,138,190,219,251,274,301,335,390,425,456],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100642054","health-benefits-of-dance-exercise-100642054",false,"NCT07615829","Health Benefits of Dance Exercise","Effects of a 6-month Dance Exercise Intervention on Physical Performance, Metabolic and Mental Health in Pre- and Post-menopausal Women","Inclusion Criteria:\n\n* Free of musculoskeletal injuries\n* Free of chronic non-communicable diseases\n* Normal menstrual cycle (for premenopausal women)\n* No recent childbirth (previous 12 months) (for premenopausal women)\n* At least 12 months since the oncet of menopause (for postmenopausal women)\n* Non smokers\n\nExclusion Criteria:\n\n* Pregnancy (for premenopausal women)\n* Contraindications to exercise training\n* Illness or other medical condition\n* Use of medication",true,"FEMALE","35 Years","70 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","In Greece, people of different age groups, including young children to older adults, participate in dance exercise training. Although it is well-known that regular participation in dancing is associated with benefits such as entertainment, socialization and increased physical activity, the long-term effects of dancing on metabolic and mental health as well as physical performance remain largely unknown. Therefore, the aim of this study is to investigate the effects of a 6-month dancing exercise intervention on metabolic and mental health and physical performance in premenopausal and postmenopausal women.",[28,29,30],"Metabolic Health","Mental Health","Physical Performance","RECRUITING","2026-06-09",{"date":34,"type":35},"2026-06-12","ACTUAL",{"date":37,"type":22},"2026-05-30",{"date":39,"type":22},"2026-12-20",{"name":41,"class":42},"University of Thessaly","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100637190","effect-of-dairy-protein-yogourt-vs-plant-based-yogourt-on-body-weight-body-composition-bone-health-and-gut-microbiota-100637190","NCT07578103","Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota","A New Focus on Protein and the Gut Microbiota to Explain Health Benefits of Dairy Foods","PROYO","Inclusion Criteria:\n\n* Postmenopausal women (absence of menstruation for at least 1 year and FSH \\> 40 IU\u002FL)\n* BMI between 27.0 and 39.9 kg\u002Fm²\n* Sedentary or moderately active\n\nExclusion Criteria:\n\n* Body weight change greater than 5 kg in the 3 months preceding the study\n* Currently dieting or following specific dietary patterns\n* Previous or planned bariatric surgery\n* Food allergies or intolerances (particularly dairy proteins and lactose)\n* Serious or problematic health conditions (e.g., renal insufficiency, diabetes, Cushing's disease, Paget's disease, parathyroid disorders, inflammatory bowel disease, uncontrolled thyroid disease, etc.)\n* Fracture within the past year\n* Hormone therapy\n* Medications affecting bone metabolism (e.g., osteoporosis treatments, anti-estrogen therapy for breast cancer, epilepsy treatments)\n* Antibiotic use within the 6 months preceding the study\n* Use of probiotic supplements (capsules)\n* More than two alcoholic drinks per day\n* Smoking\n* Drug abuse","40 Years",{"count":54,"type":22},75,[25],"The consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning. It is also well established that all proteins are not equal regarding their ability to promote health benefits. Recently, we have innovated in that matter by showing that under the context of high intake of dietary fat, the dairy protein casein was more effective than a mix of proteins representative of a western diet to prevent body weight gain and insulin resistance. This was explained in part by modifications of the gut microbiota. This finding represents the main conceptual basis of the present research program that is aimed to determine the impact of dairy protein from yogurt compared to a plant-based equivalent on body composition indicators including muscle mass and bone mineral density, in relation to the profile of the gut microbiota, the production of newly discovered protein-derived metabolites, and markers of metabolic health. This program will include a human and an animal component requiring the testing of these variables before and after a standardized intervention. The human component will be a clinical study consisting of a 12-week diet-based weight loss intervention in postmenopausal overweight women being randomly assigned to one of the three following groups: yogurt, plant-based yogurt, or kept on diet without supplements. The animal experimentation will permit to causally determine the implication of the gut microbiota in the protein effects following transfer of the human bacteria to germ free mice and validate the benefits seen in humans. It is anticipated that these two complementary investigative approaches will allow a thorough documentation of the impact of fermented dairy protein on body composition and functioning, a better understanding of the underlying mechanisms, and the identification of new biomarkers to better appreciate related health benefits.",[58,59,28,60,61,62],"Body Composition Changes","Body Weight Change","Bone Metabolism","Bone Health","Gut Microbiota","2026-05-05",{"date":65,"type":35},"2026-05-11",{"date":67,"type":35},"2023-11-01",{"date":69,"type":22},"2026-12-31",{"name":71,"class":42},"Laval University",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100606285","st-marys-assisted-reproductive-technology-and-cardiometabolic-health-modifiable-targets-for-multimorbidity-prevention-start-healthy-100606285","NCT07173569","St Mary's Assisted Reproductive Technology and Cardiometabolic Health: Modifiable Targets for Multimorbidity Prevention (START-HEALThY)","START-HEALThY","Inclusion Criteria:\n\n* In pre-conception cohort:\n\n  * Aged between 16 and 45\n  * Able to provide informed consent\n  * Either: 1) Those with a history of infertility (failure to conceive after at least 1 year of unprotected intercourse\u002F3-6 cycles of Intra-Uterine Insemination (IUI) or diagnosed cause of infertility) and accepted for IVF at The Department of Reproductive Medicine, MFT or, 2) attending for a pre-conception appointment at MFT\n  * Nulliparous (no previous pregnancies beyond 20 weeks)\n  * No pre-existing heart disease, hypertensive disease, vascular disease or diabetes\n* In post-pregnancy cohort\n\n  * Aged between 16 and 45\n  * Able to provide informed consent\n  * Participant of START clinic study (achieved pregnancy via a) IVF with or without ICSI treatment, b) spontaneous conception without medical intervention within 12 months, or c) spontaneous conception following ovulation induction for delay in spontaneous conception \\>12 months or confirmed anovulation)\n\nExclusion Criteria:\n\n\\- In all participants:\n\n* Prisoners\n* Born male at birth\n* Language barrier not overcome by telephone or video interpretation services\n* Pregnant at time of study visit\n\nPre-conception participants only:\n\n• Accepted for IVF for non-infertility reasons i.e. egg donation, egg collection, egg banking, gestational surrogacy","16 Years","45 Years",{"count":82,"type":22},120,"OBSERVATIONAL","The main causes of death in women are conditions affecting the heart and blood vessels (cardiovascular disease, CVD). Women who have difficulties getting pregnant (infertility) may be at increased risk, but the reasons for this are not clear. Infertility itself may be linked with poorer heart and blood vessel health, or fertility treatments such as in vitro fertilisation (IVF) could increase the risk.\n\nThe study aims to understand the practicalities of obtaining detailed profiling of women's pre- and post- pregnancy heart, blood vessel and metabolic health. Two groups of women in Manchester University NHS Foundation Trust, will be recruited over 2 years: 1) women planning a pregnancy, either spontaneously or with IVF treatment after infertility, 2) women who previously took part in a pregnancy health study after IVF or non-IVF conception.\n\nParticipants will attend a single research appointment where they will undergo a cardiometabolic health assessment. They will have their BMI calculated, body composition measured, a measurement of how well their blood vessels work using a blood pressure cuff around the arm and\u002For finger and blood sampling performed. A blood pressure cuff as well as a blood sugar sensor may be fitted to be worn after the appointment. Participants will be asked to complete a questionnaire(s), with follow-up for up to 13 months.\n\nThe cardiometabolic health of those who conceived with or without IVF treatment and with or without a history of infertility will be compared at both time points to investigate the possibility of links between infertility, IVF processes and CVD risk and to understand any potential barriers to recruitment of individuals at either time point to guide future studies. This information could then be used in a full-scale study, including in pregnancy, to improve care and promote lifelong health for women with infertility.",[86,87,88,89,28,90],"Maternal Cardiometabolic Health","Infertility","Assisted Reproductive Technology","Cardiovascular Health","in Vitro Fertilisation",[92,93,94],"Feasibility study","Ambulatory cardiometabolic health monitoring","Cohort","NOT_YET_RECRUITING","2026-04-27",{"date":98,"type":35},"2026-04-28",{"date":100,"type":22},"2026-05-01",{"date":102,"type":22},"2028-10-31",{"name":104,"class":42},"University of Manchester",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":112,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":124,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":43},"100585860","the-switch-substitution-of-high-with-low-ultra-processed-soy-protein-foods-in-a-guideline-based-diet-intervention-for-cardiometabolic-health-trial-100585860","NCT06907862","The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial","SWITCH","Inclusion Criteria:\n\n* Obesity (BMI and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity)\n* adults (≥18years)\n* hypertension (SBP 120-160 mmHg)\n* on stable antihypertensive, antihyperglycemic, antihyperlipidemic, or anti-obesity medications (≥3-months)\n* not planning new weight loss for the duration of the trial\n* 50% living with type 2 diabetes, HbA1c 6.5-9.0%\n\nExclusion Criteria:\n\n* Individuals with a history of major cardiovascular events in the last year (stroke or myocardial infarction)\n* type 1 diabetes diagnosis\n* recent weight loss or weight gain (≥5% over \\\u003C6 months)\n* current treatment with insulin\n* eating disorders; substance abuse disorders\n* serious depression or psychiatric disorders\n* bariatric or recent surgery (\\\u003C6 months)\n* uncontrolled hypertension (SBP\u002FDBP \\>160\u002F100 mmHg)\n* angina pectoris\n* gastrointestinal and malabsorption disorders (i.e. inflammatory bowel disease, celiac), pancreatitis, chronic kidney or liver disease, cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure), major disability or disorder requiring continuous medical attention.\n* herb or supplement use that may affect primary outcome.\n* alcohol use \\>3 drinks\u002Fday; participation in another trial.\n* allergies\u002Fintolerances to soy; allergies\u002Fintolerances to tree nuts, peanuts and seeds (the combination of all 3).\n* chronic or prescribed use of certain medications including prescription high dose NSAIDs, antacids, warfarin, medications affecting NO synthesis (i.e. sildenafil, organic nitrates, etc.)\n* acute or chronic infection (e.g. active HIV, TB, COVID-19, chronic inflammatory infections)\n* chronic inflammatory condition (such as rheumatoid arthritis)\n* use of antibiotics within 3-months of the study start","ALL","18 Years",{"count":115,"type":22},300,[25],"This is a randomized, controlled, parallel study with 3 experimental arms aimed to assess the effect of a digital dietary intervention (web-based app, online behavior change curriculum) enhanced with 10 servings of vegetables and fruit (5 as dietary advice within the app, 5 within a dehydrated vegetable and fruit blend), with or without high Ultra Processed Food (UPF) soy-containing proteins compared to standard of care (usual care) on systolic blood pressure (SBP; primary outcome), and other key cardiometabolic endpoints over 12-weeks in adults living with hypertension and obesity, 50% with type 2 diabetes. The main questions this study aims to answer are:\n\n1. Are nutrient-dense, high-UPF soy-protein foods similar (non-inferior) to low-UPF soy-protein foods in the context of a guidelines-based diet in their effect on blood pressure and other cardiometabolic risk factors?\n2. Does an enhanced digital dietary intervention lead to meaningful reductions in blood pressure and other cardiometabolic risk factors compared to standard of care?\n\nParticipants who are eligible and consent to be part of this study will be randomized to one of the following groups: 1) Active treatment (high-UPF soy-containing enhanced digital dietary intervention), 2) Reference treatment (low-UPF soy-containing enhanced digital dietary intervention), or 3) Control (standard of care).\n\nParticipant Requirements:\n\nDuring the 12-week intervention, all participants will be required to attend in-person clinic visits at baseline (week 0), week 8 and 12.\n\nBaseline Visit (Week 0): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit).\n\n* Undergo various assessments, including anthropometric measurements, office blood pressure readings, and blood sampling (via a capillary finger prick and blood sample taken by the study nurse).\n* Review the 7-day food records completed using the Keenoa mobile app one week prior to clinic visit.\n* Bring fecal and urine samples from home.\n* Complete and review all questionnaires received via email one week prior.\n\nTelephone Check-in (Week 1):\n\nOne week after beginning the study, the study staff will call participants to check in on how participants are following the protocol and answer any questions.\n\nMid-Study Visit (Week 8): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit).\n\n* Have their office blood pressure and anthropometric measurements taken.\n* Complete and review all questionnaires received via email one week prior\n* Review the 3-day food records completed using the Keenoa mobile app one week prior to clinic visit.\n\nFinal Study Visit (Week 12): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit).\n\n* Undergo various assessments, including anthropometric measurements, office blood pressure readings, and blood sampling (via a capillary finger prick and blood sample taken by the study nurse).\n* Review the 7-day food records completed using the Keenoa mobile app one week prior to clinic visit.\n* Bring fecal and urine samples from home.\n* Complete and review all questionnaires received via email one week prior.\n\nThroughout the study, participants will be asked to continue their usual lifestyle and physical activity.\n\nAdditional Requirements for Treatment Groups:\n\nParticipants randomized to the active and reference treatment groups will also be required to:\n\n* Incorporate a study vegetable and fruit blend (provided) into their daily diet for the full 12 weeks\n* Consume soy products categorized as either high ultra processed soy foods at least 4 servings per day, including at least 2 servings of ultra processed soy milk and 2 servings of other soy-based products (e.g., soy yogurt, soy burgers, or soy ground round) or non-ultra processed soy foods at least 4 servings per day, including at least 2 servings of minimally processed soy milk, 1 serving of edamame or roasted soy nuts, and 1 serving of tofu or tempeh\n* Participate in the digital dietary intervention, which includes: a health app, 7-day Kickstart Package, weekly text message support, and a 7-session online interactive program designed based on behaviour change theory\n* Attend a virtual focus group at Week 4 and complete an online feedback questionnaire",[119,120,121,122,28,123],"Hypertension in Type 2 Diabetes","Diabetes Mellitus Type 2","Dyslipidemia","Hypertension","Cardiovascular Risk Factors",[125,122,126,127,128,129],"Randomized controlled trial","Cardiometabolic health","Ultra processed food","technology-based dietary intervention","dehydrated vegetable and fruit blend",{"date":131,"type":35},"2026-05-04",{"date":133,"type":35},"2025-08-06",{"date":135,"type":22},"2028-06-30",{"name":137,"class":42},"University of Toronto",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":16,"sex":146,"minAge":113,"maxAge":80,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":166,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":43},"100629969","impact-of-training-load-on-the-gut-microbiome-and-its-relation-to-exercise-performance-muscle-phenotype-and-markers-of-overreaching-in-healthy-men-100629969","NCT07481578","Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men","ICARUS: Impact of Training Load on the Gut Microbiome and Its Relation to Exercise Performance, Muscle Phenotype, and Markers of Overreaching in Healthy Men: Phase A - Human Trial","ICARUS","Inclusion criteria:\n\n* Males between 18 and 45 years old.\n* Recreationally active individuals, with a weekly exercise training volume between one and six hours per week.\n* Good health status confirmed by a sport medical screening, which includes a sport medical questionnaire and resting electrocardiogram.\n* Body Mass Index (BMI) between 18.5 and 27.5 kg\u002Fm².\n* Masters the Dutch language.\n\nExclusion criteria:\n\n* Engagement in strenuous competitive sports one month prior to or during the study intervention.\n* Medication and vaccination: Pro- or antibiotic treatment during the past three months, non-steroidal anti-inflammatory drugs (NSAIDs) or cholestyramine during the past month, drugs interfering with intestinal permeability (e.g., prokinetics, laxatives, lubiprostone, loperamide, anti-spasmodics, linaclotide, proton pump inhibitors) during the past month. Vaccinations within one month prior to or during the study intervention.\n* Blood donations within three months or plasma donation within one month prior to or during the study intervention.\n* Inflammatory bowel disease (Crohn or colitis ulcerosa) or celiac disease.\n* Diagnosed irritable bowel syndrome.\n* Intake of any performance-enhancing medication or nutritional supplements known to modulate the gut microbiome in the two months prior to or during the study.\n* Substance abuse, including alcohol consumption of more than three units\u002Fday (weekly average).\n* Any injury or pathology considered a contraindication for performing physical exercise, as determined by the medical doctor overseeing the preparticipation medical screening.\n* No access to smartphone and\u002For computer with internet access.\n* No willingness to use the Polar Flow app and MijnEetmeter to collect physical activity, heart rate, sleep, and food intake data.\n* Concomitant participation in another interventional trial, without approval from the research team.\n* Any other reasons considered by the research team that the participant will not complete the study.","MALE",{"count":148,"type":22},45,[25],"The goal of this study is to learn how different amounts of supervised indoor cycling training change gut health (gut bacteria, the substances gut bacteria make, and the gut barrier integrity), and how these changes relate to changes in fitness, muscle health, and signs of doing too much training (a state called 'overreaching'). The study includes healthy, recreationally active men aged 18 to 45 years.\n\nThe primary questions, for which the study is powered (sufficient participants included), are:\n\n1. Does moderate load training change blood and faecal levels of butyrate (a short-chain fatty acid made by gut bacteria) after eight weeks compared with a control group?\n2. Compared to moderate load training, do higher training loads lead to different responses in blood and faecal levels of butyrate?\n\nResearchers will compare:\n\n* A control group that does not complete structured training;\n* A moderate-load training group that completes eight weeks of supervised cycling (4x\u002Fweek);\n* A high-load training group that completes four weeks of moderate-load training followed by four weeks of higher training load (twice the number of training sessions).\n\nParticipants will:\n\n* Be randomly assigned to one of the three groups;\n* Complete 8 weeks of supervised indoor cycling sessions if assigned to a training group;\n* Complete four study assessment periods (baseline, after week four, after week eight, and after a short taper (rest period);\n* Provide blood, stool, skeletal muscle, urine, saliva, and breath samples during the assessment periods;\n* Complete fitness and performance tests and questionnaires during the assessment periods.",[152,153,154,155,156,157,158,159,160,161,162,163,164,28,165],"Exercise","Overreaching","Butyrate","Gut Microbiome","Exercise Performance","Skeletal Muscle","Glucose Tolerance","Hormones","Vascular Health","Muscle Adaptation","Physical Fitness","Heart Rate Variability (HRV)","Anthropometric Measurements","Food Intake",[167,168,169,170,171,172,173,174,153,175,176,177,163,178,179,180],"Exercise training","Training load","Overload training","Fecal butyrate","Gut health","Exercise performance","Muscle phenotype","Physical fitness","Glucometabolic health","Vascular health","Muscle adaptation","Anthropometrics","Metabolic health","Food intake","2026-03-16",{"date":183,"type":35},"2026-03-19",{"date":185,"type":35},"2024-10-07",{"date":187,"type":22},"2027-05-31",{"name":189,"class":42},"Stefan De Smet",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":16,"sex":112,"minAge":80,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":206,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":43},"100628672","effect-of-prebiotics-in-saudi-adults-with-type-2-diabetes-100628672","NCT07464691","Effect of Prebiotics in Saudi Adults With Type 2 Diabetes","Effect of Prebiotics in Saudi Adults With Type 2 Diabetes: Randomized Control Trail","Inclusion Criteria:\n\n* Saudi, both males and females.\n* Aged between 45-60 years old\n* BMI between 25 - 30 kg\u002Fm2\n* No antibiotic use for the last six months\n\nCases:\n\n* Type 2 diabetes.\n* Duration of diabetes ≥ 5 years\n* HbA1c ≥ 6.5-8.0\n\nControls: (subjects with normal OGTT results)\n\n* Fasting plasma glucose (FPG) \\\u003C 100 mg\u002Fdl (5.6mmol\u002Fl)\n* A1C less than 5.7%\n* 2-hour post-load glucose \\\u003C 140 mg\u002Fdl (7.8 mmol\u002Fl)\n\nExclusion Criteria:\n\n1. Patients with Type 1 diabetes.\n2. Pregnant \\& breastfeeding females.\n3. Any serious disease such as renal or hepatic disease, thyroid functions, coeliac disease, or the presence of gastroparesis.\n4. Use of weight-loss treatments within 3 months before inclusion\n5. Diabetic patients on acarbose, metformin (\\> 1 g\u002Fday), and GLP-1 medications.\n6. Use of antibiotic drugs for the last 3 months of treatments that influence gut microbiota composition.\n7. Bypass surgery, Laparoscopic Sleeve Gastrectomy (LSG), or colon restriction.\n8. Chronic gastrointestinal disorder (except irritable bowel syndrome).\n9. Patients with a history or symptoms of obstruction or Inflammatory bowel disease\n10. Atypical diets (such as vegetarians, vegans, and heavy consumption of dietary supplements).\n11. Use of pre\u002Fprobiotics or fiber supplements within 3 months before inclusion.\n12. Any drug that can interfere with food absorption or gut flora, such as chronic consumption of loperamide, cholestyramine, antacids, H2-receptor blockers, proton pump inhibitors, fibrates, corticosteroids, or sex steroids, omega-3 unsaturated fatty acids acid, or anti-inflammatory drugs.\n13. Autonomic neuropathy\n14. Any immune-compromised disease.\n15. Daily alcohol consumption \\> 30 g.\n16. Involvement in another clinical trial in the past 6 months.\n17. Any legal incompetence or mental inability to provide consent.","60 Years",{"count":199,"type":22},100,[25],"This study will explore how a natural food ingredient called oligofructose affects blood glucose levels, lipid profiles, inflammation biomarkers, and gut bacteria in Saudi adults with type 2 diabetes. Oligofructose is a type of dietary fiber found in foods such as onions, garlic, and bananas. It is known to help the growth of \"good\" bacteria in the intestine, which may improve digestion and metabolism.\n\nA total of 100 adults (50 with type 2 diabetes and 50 without diabetes) will take part in this research. Participants will be randomly assigned to receive either oligofructose or a placebo twice daily for 12 weeks. Blood tests will be done at the beginning and at weeks 4, 8, and 12 to check changes in blood glucose, lipid profiles, and inflammation.\n\nThe goal of this study is to find out whether adding oligofructose to the diet can help people with diabetes improve their blood glucose control, reduce inflammation, and support a healthier balance of gut bacteria.",[203,28,204,155,205],"Type 2 Diabetes","Inflammation","Obesity",[207,208,155,209],"Prebiotics","Dietary supplement","Oligofructose","2026-03-09",{"date":212,"type":35},"2026-03-11",{"date":214,"type":22},"2026-09-13",{"date":216,"type":22},"2027-12-31",{"name":218,"class":42},"Princess Nourah Bint Abdulrahman University",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":112,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100583694","the-effect-of-dairy-intake-on-body-weight-and-composition-and-metabolic-health-in-adolescents-and-seniors-100583694","NCT06879652","The Effect of Dairy Intake on Body Weight and Composition and Metabolic Health in Adolescents and Seniors","Inclusion Criteria (long-term Study):\n\n* Age 15-18 years old (adolescents) or 60-80 years old (seniors)\n* BMI z-score \\>+1SD, \\\u003C+2SD (adolescents) or BMI 25-34.9 kg\u002Fm2 (seniors)\n* Waist circumference \\> 80 cm for women and \\> 94 cm for men (seniors)\n* FBG 5.6-6.9 mmol\u002FL (prediabetes)\n* Willing to follow Canada's Food Guide\n* Willing to maintain current dietary supplement use throughout the study.\n* Willing to abstain from alcohol consumption for 24 hours before all test visits.\n* Willing to avoid vigorous physical activity for 24 hours before all test visits.\n* Understands the study procedures and is willing to provide informed consent by the parent\u002Fguardian and assent by participant to participate in the study and authorization to release relevant protected health information to the study investigator.\n\nExclusion Criteria:\n\n* Fasting BG ≥ 7 mmol\u002FL\n* Blood pressure systolic ≥ 130mmHg or diastolic ≥ 80mmHg (adolescents) or systolic ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg\n* Smoking (tobacco and\u002For cannabis product use in the last 6 months)\n* Thyroid problems\n* History of CVDs, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorption syndrome, pancreatitis, gallbladder, or biliary disease.\n* Presence of gastrointestinal disorder or surgeries within the past year.\n* Use of the prescription or non-prescription drugs, herbal or nutritional supplements known to affect the outcome of the study as per the investigator's judgment (including prebiotics and probiotics).\n* Known to be pregnant, lactating, or not postmenopausal for at least a year and\u002For is taking hormonal treatments\n* Unwillingness or inability to comply with the experimental procedures\n* Known intolerance, sensitivity, or allergy to dairy, gluten, or any other study treatments.\n* Consumption of protein powders\u002Fsupplements\n* Extreme dietary habits (e.g., Atkins diet, very high-protein diets, etc.)\n* Weight gain or loss of \\> 5% in the previous three months.\n* Excessive alcohol intake (more than 2 drinks per day or 9 per week)\n* Restrained eating, identified by a score of ≥11 on the Eating Habits Questionnaire\n\nInclusion Criteria (short-term study):\n\n* Age 14-18 years old (adolescents) or 60-75 years old (older adults)\n* BMI z-score \\>+1SD, \\\u003C+2SD (adolescents) or BMI 25-30 kg\u002Fm2 (older adults)\n* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study.\n* Willing to maintain current dietary supplement use throughout the study. On study visit days, subject agrees not to take any supplements until dismissal from the Nutrition Intervention Center.\n* Willing to abstain from alcohol consumption for 24hrs prior to all study visits.\n* Willing to avoid vigorous physical activity for 24hrs prior to all study visits.\n* Willing to refrain from cannabis use throughout the entire duration of the study.\n* Willing to refrain from protein supplement use (e.g. protein powder) throughout the entire duration of the study.\n* Understands the study procedures, provides informed consent to participate in the study, and authorizes release of relevant protected health information to the study investigator.\n\nExclusion Criteria (short-term study):\n\n* Smoking\n* Thyroid problems\n* Lactose intolerance and\u002For allergies, intolerances, or sensitivities to study treatments\n* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, malabsorptive syndrome, pancreatitis, gallbladder or biliary disease\n* Presence of gastrointestinal disorder or surgeries within the past year.\n* Inability to comply with the experimental procedures and follow our safety guidelines\n* Regular breakfast skipping (\\>3 days a week)\n* On a special diet (e.g. ketogenic, Atkins, high protein) or restrained eaters as identified by a score of \\>20 on the Eating Attitudes Questionnaire\n* Difficulties with eating or swallowing\n* Fasting blood glucose \\>5.6mmol\u002FL measured at screening\n* Uncontrolled hypertension (systolic blood pressure \\>120mmHg, diastolic blood pressure \\>80mmHg) as defined by the average blood pressure measured at screening\n* Weight gain or loss of \\>10lbs in previous three months\n* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect outcome of the study as per investigator's judgement","14 Years","80 Years",{"count":228,"type":22},240,[25],"The goal of this study is to examine how regular dairy intake affects body weight, body composition, and metabolic health in overweight and obese adolescents (ages 15-18) and older adults (ages 60-80) over six months. We are inviting eligible individuals to participate in this study at the Nutrition Intervention Center, Department of Nutritional Sciences, University of Toronto. Participants will be randomly divided into two groups. The intervention (dairy) group will consume three servings of dairy per day (milk, yogurt, and cheese) before breakfast, lunch, and dinner. The control (low-dairy) group will continue their usual diet, keeping dairy intake to less than one serving per day.\n\nParticipants will have biweekly sessions with a registered dietitian to be guided to follow Canada's Food Guide, monitor their dietary intake and ensure compliance with their assigned group. In addition, they will visit the Nutrition Intervention Center at weeks 0, 12, and 24 for anthropometric and body composition assessments (weight, height, waist circumference, blood pressure, lean mass, and fat mass), resting metabolic rate, (gait speed, grip strength, and chair stand test just for older adults) and blood markers (fasting blood glucose, insulin, C-peptide, HbA1c, lipid profiles, and inflammatory markers). Each visit will take approximately 4 hours.\n\nBefore each visit, the participants will be asked to fast overnight for 12 hours, maintain their usual diet and sleep patterns, and avoid exercise and alcohol the day before. The participants will be compensated for their time and travel expenses.\n\nOur secondary objective is to compare the effects of dairy and plant-based alternative products on blood sugar and appetite regulation in adolescents and older adults. Participants will be asked to come to the Nutrition Intervention Center on 3 separate occasions: once for an in-person screening lasting approximately 30 min and 2 times for study visits lasting approximately 2.5 hrs each. The entire study will take at least 2 weeks to complete. You will be asked to fast for 12 hrs (overnight) before each study visit. You will also be instructed to maintain the same dietary and sleep patterns and refrain from exercise and alcohol consumption on the days before the study visits. During these study visits, you will be asked to consume either a dairy or a plant-based alternative product as well as a pizza meal. You will periodically fill out questionnaires rating your feelings and perceptions, and provide blood samples through finger pricks and intravenously through your forearm to measure blood sugar, insulin, hormones, and amino acids. You will be compensated for your time and travel expenses.",[232,28,233],"Dairy Consumption","Obesity Prevention",[235,205,236,237,238,239,240,241],"Dairy intake","Type2 Diabetes","HbA1c","BMI z-score","Insulin resistance","Adolescents","Seniors","2026-03-03",{"date":244,"type":35},"2026-03-05",{"date":246,"type":22},"2026-06-01",{"date":248,"type":22},"2028-06",{"name":137,"class":42},2,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":16,"sex":112,"minAge":258,"maxAge":19,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":43},"100337213","health-environment-and-action-in-louisville-heal-green-heart-louisville-project-100337213","NCT03670524","Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project","HEAL","Inclusion Criteria:\n\n* 30-70 years of age.\n* Live within the targeted study location\n\nExclusion Criteria:\n\n* Unwilling or unable to provide consent.\n* HIV\u002FAIDS, active treatment for cancer, active bleeding including wounds.\n* Body weight less than 100 pounds or BMI\\>40.\n* Prisoners and other vulnerable populations.\n* Anyone that PI thinks is unsafe to participate in study.","30 Years",{"count":260,"type":22},835,[25],"The purpose of this study is to examine how the environment and neighborhood characteristics affects the health of the area residents. The study will help determine how changing neighborhood characteristics, such as green space, affect heart health, risk factors for other diseases, sense of well- being or neighborhood cohesion.",[264,28],"Cardiovascular Diseases","2026-02-06",{"date":267,"type":35},"2026-02-10",{"date":269,"type":35},"2018-05-03",{"date":271,"type":22},"2028-10-30",{"name":273,"class":42},"University of Louisville",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":16,"sex":17,"minAge":113,"maxAge":80,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":286,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":43},"100613577","womens-hormonal-and-metabolic-wellbeing-study-100613577","NCT07268404","Women's Hormonal and Metabolic Wellbeing Study","A 12-Week Virtual, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of Daily Nouri Hormone Balance Probiotic on Metabolic, Inflammatory, and Symptom Outcomes in Women","Inclusion Criteria:\n\n* Self-reported irregular menstrual cycles, defined as one or more of the following:\n\n  * Cycle length typically \\>35 days OR \\\u003C21 days\n  * Fewer than 9 menstrual periods in the past year\n  * Unpredictable cycle timing (varies by \\>7 days month-to-month)\n  * Irregular cycles present for ≥6 months\n* One or more of the following hormonal balance concerns: skin, unwanted hair growth, hair thinning, weight concerns)\n* Self-reported emotional symptoms that fluctuate with menstrual cycle, including:\n\n  * Mood swings or irritability\n  * Feelings of stress or tension\n  * Low mood or feeling down\n  * Difficulty with emotional regulation\n* Not currently using hormonal therapies, metformin, GLP-1 receptor agonists, or anti-androgens.\n* If taking supplements for menstrual\u002Fhormonal support: willing to discontinue for 2-week washout before baseline\n* Weight stable (+ 5 pounds) for the past 2 months, not planning to start a new diet, exercise program, or medications during study\n* Able to provide electronic informed consent.\n* Willing to complete online surveys and at-home DBS sample collection.\n* Negative home pregnancy test at baseline.\n* Access to a computer or smartphone and reliable internet connection.",{"count":282,"type":22},60,[25],"The goal of this clinical trial is to learn if Daily Nouri Hormone Balance Probiotic blend can improve metabolic, inflammatory, and symptom outcomes in women.\n\nParticipants will:\n\n* Take the probiotic blend or placebo every day for 12 weeks\n* Complete virtual assessments and report symptoms throughout the study",[28],[287,288,289,290],"dietary supplement","quality of life","women's health","hormone balance","2025-12-12",{"date":293,"type":35},"2025-12-19",{"date":295,"type":22},"2025-12",{"date":297,"type":22},"2026-12",{"name":299,"class":300},"Daily Nouri","INDUSTRY",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":16,"sex":112,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":331,"leadSponsor":333,"locationsCount":43},"100612609","defining-the-human-insulin-resistance-molecular-network-signature-100612609","NCT07255807","Defining the Human Insulin Resistance Molecular Network; SIGNATURE","sIgnatuRe: Defining the Human Insulin Resistance Molecular Network","SIGNATURE","Inclusion Criteria:\n\n* Age: 25-55 years\n* Body Mass Index (BMI): 18-30 kg\u002Fm²\n* Healthy (no diagnosed chronic diseases)\n* Able and willing to comply with study procedures\n\nExclusion Criteria:\n\n* Smoking or nicotine use, current or within the past 5 years\n* Alcohol intake exceeding 10 units per week\n* Hemoglobin A1c (HbA1c) \\> 48 mmol\u002Fmol (indicative of diabetes or prediabetes)\n* Chronic diseases (e.g., cardiovascular disease, diabetes, etc.)\n* Chronic medication use, including hormonal treatments\n* High physical activity levels (more than 3 hours per week of moderate to vigorous exercise)\n* Pregnancy or within 3 months postpartum\n* Breastfeeding or within 3 months of cessation\n* Abnormal routine blood markers (as defined in lab screening)\n* Blood donation within the past 2 months","25 Years","55 Years",{"count":312,"type":22},80,[25],"The goal of this intervention study is to learn more about what causes insulin resistance in otherwise healthy adults, and how short-term changes in physical activity or diet may influence it. The study includes healthy male and female participants aged 25 to 55 years, who meet specific health criteria.\n\nThe main questions it aims to answer are:\n\nDoes the cause of insulin resistance vary between individuals due to their genes and lifestyle?\n\nCan the investigators identify different types (sub-phenotypes) of insulin resistance at the molecular level?\n\nResearchers will compare groups who either reduce their physical activity for 14 days or consume a high-fat diet for 3 days, to see how these changes affect insulin sensitivity and related biological markers.\n\nParticipants will:\n\n* Complete a health screening and be assessed for eligibility\n* Undergo baseline testing to measure insulin sensitivity, physical activity, diet, and metabolic health\n* Be randomly assigned to one of two short-term interventions (14 days of reduced physical activity, or 3 days of a high-fat, high-calorie diet)\n* Repeat selected tests after the intervention to assess changes\n\nThis study will help researchers better understand how lifestyle and biology interact in the development of insulin resistance, even in people who are otherwise healthy.",[28,316],"Insulin Sensitivity\u002FResistance",[318,28,319,320,321,322,323,324,325,326],"Insulin Resistance","Glucose Metabolism","Lifestyle Interventions","Physical Inactivity","High-Fat Diet","Molecular Mechanisms","Insulin Sensitivity","Metabolic Phenotyping","Human Intervention Study","2025-11-20",{"date":329,"type":35},"2025-12-01",{"date":329,"type":22},{"date":332,"type":22},"2038-06-30",{"name":334,"class":42},"University of Copenhagen",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":16,"sex":112,"minAge":341,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":344,"conditions":345,"keywords":358,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":4},"100609070","healthspan-connect-programme-of-research-100609070","NCT07209774","Healthspan Connect Programme of Research","Inclusion Criteria:\n\n* Age 12 years or older at time of enrollment.\n* Resident in the United Kingdom.\n* Able to participate in the study using digital tools (smartphone, tablet, or computer).\n* Able to provide informed consent (digital consent accepted).\n* For participants aged 12-15 years: must have parent\u002Fguardian consent in addition to their own assent.\n\nExclusion Criteria:\n\n* Individuals unable to provide informed consent (or parental consent where applicable).\n* Individuals not resident in the UK.\n* Individuals unable to complete study requirements due to lack of internet access, inability to use digital devices, or severe digital literacy barriers.","12 Years",{"count":343,"type":22},100000,"Healthspan Connect is a new research programme designed to understand what helps people stay healthy as they age. The programme will explore how lifestyle, environment, genetics, and social factors influence healthy ageing and overall wellbeing.\n\nThe programme will recruit participants aged 12 years and older across the UK. By including adolescents, the programme aims to understand how early life behaviours and experiences shape long-term health. There is no upper age limit, and people from all backgrounds are encouraged to participate. Special pathways ensure that young participants provide consent in an age-appropriate way.\n\nHealthspan Connect is a digital and home-based study, meaning participants can take part from home using smartphones, computers, and online surveys. Participants may also be asked to collect samples such as blood, saliva, stool, urine, or other biological specimens at home using easy-to-use kits. In some sub-studies, participants may be invited to attend research visits for additional tests, scans, or clinical assessments. Family members and close contacts may also be invited to participate in some studies.\n\nThrough Healthspan Connect, researchers aim to:\n\n* Identify the biological, environmental, and social factors that help people live longer, healthier lives.\n* Understand how different groups, including those historically underrepresented in research, experience ageing.\n* Explore ways to support behaviour changes that improve health over the lifespan.\n* Provide near real-time information to inform health policies and interventions.\n\nParticipants may also be asked for permission to link their information with health records, education records, and environmental data to better understand health outcomes over time.\n\nThis programme will serve as a flexible platform for multiple sub-studies, allowing participants to contribute to a wide range of research questions related to healthy ageing, resilience, and long-term health. All data and biological samples will be stored securely and used to advance scientific knowledge, with participant privacy carefully protected.",[346,29,347,348,349,350,351,89,28,352,353,354,355,356,357],"Cancer","Ageing Well","Resilience","Cognitive Health","Psychological Health","Environmental Health Effects","Neurological Health","Musculoskeletal Health","Respiratory Health","Allergies","Eye Health","Other",[359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380],"Healthy ageing","Healthspan","Longevity","Ageing resilience","Life course determinants","Multiple long-term conditions","Digital health research","Remote monitoring","Mobile health (mHealth)","Wearables","Biobank","Biological specimen collection","Home-based sample collection","Epidemiology","Longitudinal cohort study","Adolescents and ageing","Underrepresented populations in research","Behaviour change","Environmental exposures","Data linkage","Electronic health records (EHR)","United Kingdom","2025-09-29",{"date":383,"type":35},"2025-10-07",{"date":385,"type":22},"2026-01-05",{"date":387,"type":22},"2056-01-05",{"name":389,"class":42},"King's College London",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":16,"sex":112,"minAge":113,"maxAge":4,"enrollmentInfo":396,"targetDuration":398,"studyType":83,"phases":4,"briefSummary":399,"conditions":400,"keywords":410,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":250},"100589754","apple-health-study-100589754","NCT06958523","Apple Health Study","Inclusion Criteria:\n\n* Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);\n* Live in the United States of America;\n* Have an iPhone;\n* Have installed Apple Research app on your iPhone;\n* Be comfortable communicating in written and spoken English;\n* Be willing and able to provide informed consent to participate in the Study.\n\nExclusion Criteria:\n\n* Share your iCloud account, iPhone, or devices that collect health data such as Apple Watch with anyone else, because it could result in sharing another person's health information with the Study, making it challenging for researchers to use your information.",{"count":397,"type":22},500000,"5 Years","The Apple Health Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health.\n\nTo enroll, US residents who have an iPhone can download the Apple Research app from the App Store and go through the introduction and informed consent for the Apple Health Study. This study is fully remote, and all are invited to enroll if the eligibility criteria are met.\n\nParticipants will be asked to complete tasks and surveys, using their iPhone and Apple Research app which include:\n\n* Selecting the types of data they would like to share with the study such as health and sensor data\n* Completing tasks and surveys including areas such as personal demographic information, personal medical history, family history, and social determinants of health",[29,401,152,159,28,402,403,404,405,406,407,408,409],"Sleep","Hearing","Aging","Lifestyle Factors","Functional Capacity","Neurological Conditions","General Health","Wellbeing","Women&#39;s Health",[394,411,412,413,414,415],"Large Scale Digital Study","Digital Biomarkers","Research App","Apple Research App","iPhone","2025-07-24",{"date":418,"type":35},"2025-07-29",{"date":420,"type":35},"2025-02-12",{"date":422,"type":22},"2030-02",{"name":424,"class":300},"Apple Inc.",{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":112,"minAge":309,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":438,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":454,"locationsCount":43},"100482610","viome-nutritional-programs-to-improve-clinical-outcomes-for-metabolic-conditions-100482610","NCT05564273","Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions","Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Metabolic Conditions","Inclusion Criteria:\n\n* Resident of the United States\n* Females and males ages 25-75 (inclusive)\n* Able to speak and read English\n* No unexplained weight loss, fevers, anemia, or blood in stool\n* Willing and able to follow the trial instructions, as described in the recruitment letter\n* Signed and dated informed consent prior to any trial-specific procedures.\n* Fasting insulin level \\>=15 uIU\u002FmL or fasting glucose \\>= 100 mg\u002FdL within the last 3 months, verified from medical records\n\nExclusion Criteria:\n\n* Unwilling to change current diet\n* Unwilling to go to Quest\n* Prior use of Viome products or services\n* Antibiotic use in the previous 4 weeks\n* Women who are pregnant (current or planned in the next 4 months), or breastfeeding\n* \\\u003C 90 days postpartum\n* Active infection\n* Unable or unwilling to use Viome's App on an iPhone or Android smartphone\n* Significant diet or lifestyle changes in the previous 1 month\n* IBD diagnosis\n* Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial\n* Cancer therapy within the previous 1 year\n* Major surgery in the last 6 months or planned in the next 4 months\n* Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)\n* Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)\n* Prescribed any drug(s) that may interact with the supplement formulations\n* Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements such as:\n\nPregnancy Breastfeeding Minors GERD Gastric Ulcers Ulcerative Colitis Crohn's Disease Kidney Impairment (kidney cysts, kidney disease) Liver Condition (gallstones, cholecystitis, cirrhosis, hepatitis, hepatitis a, hepatitis b, hepatitis c, NAFLD\u002FNASH, etc) HIV SIBO CuminAllergy GymnemaAllergy BacopaAllergy CitrusAIlergy LamiaceaeAllergy SageAllergy YeastAllergy MulberryAllergy ChicoryAllergy\n\n* Allergies to any study-specific supplement ingredients\n* Currently on a specific diet:\n\nFODMAP KETO PALEO\n\n* Gastrointestinal disease including:\n\n  * GI surgery except:\n\n    * Appendectomy and benign polypectomy\n* Esophagitis\n* Celiac disease\n* GI malignancy or obstruction\n* Peptic Ulcer Disease\n* Duodenal or gastric ulcer disease","75 Years",{"count":434,"type":22},150,[25],"US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will not utilize clinical sites.",[28],[439,440,441,442,237,443,444,445,446,447],"BMI","Framingham Risk Score","Insulin","blood glucose","hsCRP","Lipids","Supplements","Vitamins","diet","2025-01-27",{"date":450,"type":35},"2025-01-29",{"date":452,"type":35},"2023-10-13",{"date":297,"type":22},{"name":455,"class":300},"Viome",{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":112,"minAge":113,"maxAge":4,"enrollmentInfo":464,"targetDuration":466,"studyType":83,"phases":4,"briefSummary":467,"conditions":468,"keywords":471,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":43},"100564033","early-changes-in-metabolic-health-in-breast-cancer-patients-initiating-endocrine-therapy-100564033","NCT06623903","Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy","Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study","EMETA","Inclusion Criteria:\n\n* Age ≥18 years\n* Invasive ER+ breast cancer\n* No diabetes treatment\n* Planned for initiation of any adjuvant endocrine therapy.\n\nExclusion Criteria:\n\n* Pregnancy or lactation,\n* Psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.",{"count":465,"type":22},112,"3 Months","This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy. Furthermore, how these changes are affected by estrogen level, treatment type, and patient characteristics. The hypothesis is, that initiation of antihormone therapy for early breast cancer patients is associated with an early deterioration in metabolic health after 3 months. This includes increased BMI (Body Mass Index), waist- and hip circumference, blood pressure, blood sugars, and lipids compared to when the patients initiate antihormone therapy. Concurrently, estradiol levels are expected to decrease. An estimated 112 patients initiating antihormone therapy at the Dept. of Oncology, Aarhus University Hospital (AUH) will be included in the study over 6 months from autumn 2024. Patients will have a metabolic screening on the day of initiating antihormone therapy and at 3-month antihormone treatment follow-up. The two metabolic screenings each consists of biometric measurements and a blood sample.",[469,28,470],"Early Breast Cancer","Estrogen Receptor Positive Breast Cancer",[472,179,473],"Early breast cancer","Endocrine therapy","2024-10-01",{"date":476,"type":35},"2024-10-02",{"date":478,"type":22},"2024-11-01",{"date":480,"type":22},"2025-07-31",{"name":482,"class":42},"Aarhus University Hospital"]