[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"body-weight-changes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:body-weight-changes":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,76,107,134,156,180],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100551777","whole-foods-for-teens-a-pilot-dietary-intervention-to-reduce-body-adiposity-in-adolescents-with-obesity-100551777",false,"NCT06464497","Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity","Inclusion Criteria:\n\nFor this study, eligible adolescents will be those that:\n\n1. 10-18 years of age at time of initial screening;\n2. living at home full-time with the enrolled parent or caregiver (≥80% in primary residence);\n3. obesity defined as a body mass index (BMI) greater than or equal to 95th percentile for age and gender based on standardized CDC growth curves;\n4. reside within greater Middle Tennessee area and has enrolled parent\u002Fcaregiver willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;\n5. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups causing anaphylaxis);\n6. are willing and able to participate in an 8-week diet study that encourages preparing and eating healthy foods and snacks for 8 weeks with parental or caregiver support;\n7. have parental or caregiver commitment to participate in the research study;\n\nFor this study, eligible adult parents or caregivers will be those that:\n\n1. adult parent or primary legal caregiver (greater than or equal to 25 years of age) of an enrolled adolescent;\n2. live with the adolescent full-time (≥80% in primary residence);\n3. have 1 or more metabolic risk factor(s) and\u002For metabolic condition(s) (e.g., overweight\u002Fobesity, hypertension, hypercholesterolemia or dyslipidemia, hyperglycemia \\[elevated fasting blood glucose ≥100 mg\u002FdL\\] and\u002For prediabetes, history of gestational diabetes, polycystic ovarian syndrome, type 2 diabetes, non-alcoholic fatty liver disease);\n4. reside within greater Middle Tennessee area and are willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;\n5. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups);\n6. are able to participate in a study program that encourages preparing and eating healthy foods and snacks for 8 weeks with most preparation\u002Fcooking of meals\u002Fsnacks at home;\n\nExclusion Criteria:\n\nAdolescent exclusion criteria include:\n\n1. Outside of the specified age range;\n2. not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);\n3. BMI less than 95th percentile for age and gender;\n4. pregnant or lactating;\n5. no eligible enrolled parent or caregiver or lack of parental\u002Fcaregiver commitment to participate in study;\n6. food allergy to 3 or more food groups; dietary restrictions or medical condition that prohibits participation in a diet study;\n7. use of medications that cause weight loss or diabetes medications;\n8. active participation in a weight loss or intense lifestyle modification program;\n9. limited English-language proficiency;\n10. participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;\n11. adolescents who display dissenting behaviors during baseline data collection;\n12. adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;\n\nAdult Parent or Caregiver exclusion criteria include:\n\n1. not parent\u002F or legal caregiver;\n2. not living in a household full-time with enrolled adolescent (less than 80% time spent away from primary residence);\n3. lack of metabolic condition(s) per inclusion criteria;\n4. special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n5. limited English-language proficiency;\n6. participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;\n7. parent or caregivers who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;","ALL","10 Years",{"count":18,"type":19},60,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study will address the following aims:\n\nAim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity.\n\nAim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention.\n\nHypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group.\n\nAim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention.\n\nHypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and\u002For waist circumference at the 8-week follow-up than those in the control group.\n\nSecondary Aims:\n\nAim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period.\n\nHypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group.\n\nAim 3: Conduct post-intervention family focus groups to identify how individual\u002Ffamily needs and preferences and social determinants of health (SDOH) may be perceived barriers and\u002For facilitators of diet adherence to a whole foods diet pattern.",[25,26,27],"Obesity, Childhood","Diet, Healthy","Body Weight Changes","RECRUITING","2026-03-18",{"date":31,"type":32},"2026-03-23","ACTUAL",{"date":34,"type":32},"2025-03-24",{"date":36,"type":19},"2027-04-30",{"name":38,"class":39},"Vanderbilt University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":15,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":40},"100575839","the-precision-nutrition-new-york-study-100575839","NCT06777498","The Precision Nutrition New York Study","Optimizing Dietary Fiber Eating Patterns to Prevent Obesity and Resulting Metabolic Disorders","PNNY","Inclusion Criteria:\n\n* Age is between 21-50 years\n* BMI is between 25-30. You can check your BMI here: https:\u002F\u002Fwww.cdc.gov\u002Fbmi\u002Fadult-calculator\u002Findex.html\n* Must be able to have height, weight, waist, and hip circumference, and body composition measured during the study\n* Must be able to provide saliva samples.\n* Must be able to provide a phone number and email address at which the study investigators can contact for study-related matters.\n* Must be able to increase dietary fiber intake to the recommended level following the instructions on the USDA MyPlate website: https:\u002F\u002Fwww.myplate.gov\u002Fmyplate-plan\n* Must be able to provide food records of everything consumed (food, beverage, and supplements) on one weekday and one weekend day (example Tuesday, Saturday) every week during the study. This will be done using an online survey.\n* Must be able to provide 10 stool samples over 11 weeks of the study duration. 18) Must have stable weight (within ±3% of usual body weight) for the last two months.\n* Must be able to to take an online survey to assess recent dietary fiber intake to determine eligibility.\n\nExclusion Criteria:\n\n* Electronic medical implant, for example, a pacemaker.\n* An existing, UNTREATED, thyroid condition.\n* Use of systemic antibiotics (intravenous injection, intramuscular, or oral) within the last 4 months.\n* An acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).\n* A chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.\n* Any suspected state of immunosuppression or immunodeficiency including HIV.\n* A history of active UNTREATED gastrointestinal disorders or diseases including\n\n  1. Inflammatory bowel disease (IBD)\n  2. Ulcerative colitis (mild-moderate-severe)\n  3. Crohn's or celiac disease\n  4. Indeterminate colitis\n  5. Irritable bowel syndrome (IBS) (moderate-severe)\n  6. Persistent, infectious gastroenteritis, colitis or gastritis\n  7. Persistent or chronic diarrhea of unknown etiology\n  8. Clostridium difficile infection (recurrent)\n  9. Chronic constipation\n* Previously had bariatric surgery.\n* An unstable dietary history as defined by major changes in diet during the previous month. For example, elimination or significantly increased intake of a major food group in the diet.\n* Recent history of chronic alcohol consumption defined as more than 5 drinks (or servings) of alcohol per day.\n* Female participants: pregnant\u002Flactating.",true,"21 Years","50 Years",{"count":53,"type":19},15,[22],"Dietary fiber has been shown to have beneficial effects on human health through its impact on microbes present in the gut. However, these effects can vary between individuals, and everyone may not reap the same health benefits by eating the same sources of fiber. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes change in response to different sources of fiber would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber. The objective of this study is to evaluate candidate predictors of gut microbiota response to fiber sources from either whole grains or fruits and vegetables.",[57,27],"Body Composition Changes",[59,60,61,62,63,64,65,66],"dietary fiber","gut microbiome","gut microbiota","short-chain fatty acids","SCFAs","whole grains","fruits","vegetables","2025-07-09",{"date":69,"type":32},"2025-07-11",{"date":71,"type":32},"2025-01-13",{"date":73,"type":19},"2025-12-31",{"name":75,"class":39},"Cornell University",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":20,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":40},"100488792","phase-4-effect-of-erugliflozin-on-liver-fat-liver-fibrosis-and-glycemic-control-in-type-ii-dm-patients-with-nashnafld-100488792","NCT05644717","Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH\u002FNAFLD","Effects of Ertugliflozin on Liver Fat, Liver Fibrosis & Glycemic Control in Subjects With Type 2 Diabetes Mellitus (T2DM) & Non-Alcoholic Fatty Liver Disease \u002FNon-Alcoholic Steatohepatitis","Ertu-NASH","Inclusion Criteria:\n\n* Patient able to provide written informed consent\n* Adult males \\& females between 18 to 65 years\n* SGLT2i and insulin naïve patients\n* BMI \\>23 Kg\u002Fm2\n* HbA1C % ≥ 6.5 to 10\n* Documented hepatic steatosis or fatty liver disease on Ultrasound\n* Patient with Type II Diabetes Mellitus\n\nExclusion Criteria:\n\n* History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study.\n* Pioglitazone use in the past 6 months\n* History of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study.\n* History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study.\n* History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome)\n* History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and\u002For HIV\n* History of recurrent UTIs and mycotic infection.\n* Severely ill patients (who have high grade fever, sepsis or acute infection)\n* Pregnant woman, lactating woman or planning pregnancy during study duration\n* History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines).\n* History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and\u002For laboratory tests\n* Alcohol intake 10 - 30 g\u002Fday (three drinks per day) within the previous year\n* Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines.\n* Severe hepatic impairment ( AST \\& ALT levels \\> 3 times upper limit normal","18 Years","65 Years",{"count":87,"type":19},164,[89],"PHASE4","Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \\& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)\u002FNon-Alcoholic Steatohepatitis (NASH)",[92,93,94,27,95,96],"Liver Fat","Liver Fibrosis","Glycemic Control","Waist Circumference","Tolerance","2025-03-19",{"date":99,"type":32},"2025-03-21",{"date":101,"type":32},"2023-03-01",{"date":103,"type":19},"2025-12-01",{"name":105,"class":106},"Getz Pharma","INDUSTRY",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":15,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":20,"phases":118,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":40},"100456216","bio-impedance-monitoring-as-a-tool-to-assess-fluid-status-in-the-pediatric-surgical-patient-pedfluid-study-100456216","NCT05220709","Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient? (PedFluid Study)","Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient: Can we Measure a Fluid Shift","Inclusion Criteria:\n\n* Scheduled for elective surgery or investigation under general anesthesia\n* Day care or inpatient hospitalisation\n\nExclusion Criteria:\n\n* If sedation is needed instead of general anesthesia\n* Critically ill patients for urgent surgery\n* Patients who cannot lie still for performing correct measurements on the bio impedance monitor\n* No informed consent obtained","1 Month","16 Years",{"count":117,"type":19},100,[22],"The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4\u002F2\u002F1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. The study tends to validate the use of bio impedance measurements for registering fluid shifts in the pediatric surgical patients.",[121,27,122],"Fluid and Electrolyte Imbalance","Children, Only",[124],"bio impedance spectroscopy","2025-03-04",{"date":127,"type":32},"2025-03-05",{"date":129,"type":32},"2022-04-05",{"date":131,"type":19},"2026-05-31",{"name":133,"class":39},"University Hospital, Antwerp",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":15,"minAge":84,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":40},"100548845","prediction-of-response-to-bariatric-surgery-in-patients-with-severe-obesity-100548845","NCT06426290","Prediction of Response to Bariatric Surgery in Patients With Severe Obesity","Prediction of Response to Bariatric Surgery Treatment in Patients Suffering From Severe Obesity, Based on the Scales of the MMPI-2-RF Questionnaire Carried Out Preoperatively","PREDI-CHIRBA","Inclusion Criteria:\n\n* Having been treated in the Nutrition department for severe obesity and considered for bariatric surgery because having met the criteria validating bariatric surgery:\n* Having passed the MMPI-2-RF questionnaire between January 1, 2014 and December 31, 2023 in the preoperative phase, as part of psychological follow-up\n* Having benefited from bariatric surgery or patients who have abandoned the surgery plan for a reason other than a medical contraindication.\n* Informed of the study, having agreed to participate and not having opposed the use of their data\n\nExclusion Criteria:\n\n* Subjects who generated an invalid MMPI-2-RF questionnaire, according to the test validity criteria (verified by the principal investigator)\n* Subjects who expressly objected to the use of their data for this study\n* Subjects who have not undergone bariatric surgery due to a medical contraindication.\n* Patient unable to understand the study or complete the post-operative phase visit\n* Persons under guardianship or curators or under legal protection",{"count":143,"type":19},360,"OBSERVATIONAL","This is an retrospective and prospective (ambispective) study with data collection from volunteer patients who passed an MMPI-2-RF (Minnesota Multiphasic Personality Inventory-2-Restructured form) questionnaire in the preoperative phase of a bariatric surgery project.\n\nThe evolution of their BMI will be correlated to psychological dimensions collected in patient questionnaires, before and after bariatric surgery.\n\nThe presence of possible risk factors such as depression, anxiety, eating disorders, quality of life, satisfaction and the perception of body, could make it possible to establish adapted therapies before surgery, in order to attenuate or eliminate the presence of these factors, and improve BMI evolution and bariatric surgery success.",[27],"2024-08-19",{"date":149,"type":32},"2024-08-20",{"date":151,"type":32},"2024-05-10",{"date":153,"type":19},"2027-12",{"name":155,"class":39},"Centre Hospitalier de Moulins Yzeure",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":49,"sex":15,"minAge":84,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":20,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":40},"100558620","fatmax-training-on-metabolic-and-epigenetic-parameters-100558620","NCT06553482","FatMax Training on Metabolic and Epigenetic Parameters","Impact of Exercise Training at Maximal Fat Oxidation (FatMax) Intensity on Metabolic and Epigenetic Parameters in Subjects With Excessive Body Mass: Study Protocol of a Randomized Controlled Trial","Inclusion Criteria:\n\n* Both genders\n* Daily energy expenditure \\\u003C4 METs\n* Body mass index ≥25 kg\u002Fm2\n* Acceptance of informed consent\n\nExclusion\u002Felimination Criteria:\n\n* ≥100 ml of alcohol consumption per week\n* Consume a dietary supplement or pharmacological treatment\n* Have limitations to perform regular physical activity\n* Have a chronic non-communicable disease\n* Answer \"yes\" to any of the questions on the Physical Activity Readiness- Questionnaire for Everyone (PAR-Q+); which represents a health risk.\n* \\\u003C80% attendance at exercise sessions","35 Years",{"count":165,"type":19},156,[22],"Exercise is an essential pillar for the health of all individuals, as it contributes to physical, mental, and emotional well-being. Various international organizations, such as the World Health Organization, advocate for the integration of exercise into healthy lifestyles, recognizing its im-portance in disease prevention and improving quality of life. However, despite the general consensus on its value, there is no universal agreement on specific prescriptions for vulnerable groups, highlighting the need for personalized approaches that consider the unique characteristics and needs of each individual. It has been proposed that a moderate aerobic exercise training program could promote positive outcomes in individuals living with overweight and obesity, particularly with an emphasis on reducing injury risk, ensuring high adherence, and achieving favorable health changes. In this regard, the present protocol establishes the basis for a randomized clinical trial based on exercise prescription at the maximal fat oxidation rate in young individuals with overweight and obesity, with a duration of 16 weeks. Throughout the study, biochemical changes (cholesterol, glucose, triglycerides, and inflammatory markers), metabolic changes (de-termination of fat and carbohydrate utilization rates during rest and exercise), and epigenetic changes (focusing on microRNAs associated with adipogenesis, inflammation, and fat metabolism) will be monitored.",[169,27],"Overweight and Obesity","NOT_YET_RECRUITING","2024-08-13",{"date":173,"type":32},"2024-08-15",{"date":175,"type":19},"2025-01-01",{"date":177,"type":19},"2027-01-01",{"name":179,"class":39},"Universidad Autonoma de Baja California",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":15,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":40},"100557165","body-composition-growth-and-maturation-of-triathletes-100557165","NCT06534567","Body Composition, Growth, and Maturation of Triathletes","Association of Body Composition, Growth, and Maturation Status With Physical Activity and Adherence With Mediterranean Diet in Youth Triathletes","Inclusion Criteria:\n\n* Acceptation of informed consent by parents\n\nExclusion Criteria:\n\n* No attendance to body composition evaluation\n* Reporting less than 80% of assistance to physical activity sessions reported by trainer","5 Years","17 Years",{"count":117,"type":19},"The goal of this observational study is to determine if physical activity and the adherence to a Mediterranean diet have a relationship with body composition, growth, and maturation status in youth triathletes. The main question it aims to answer is:\n\n• Is body composition (fat and muscle) determined primarily by growth and biological maturation or by physical activity and the Mediterranean diet in youth triathletes? Participants already have been evaluated in body composition, mediterranean diet adherence and practical of physical activity during 3 years.",[192,27],"Diet Habit","2024-08-01",{"date":195,"type":32},"2024-08-05",{"date":197,"type":32},"2021-11-01",{"date":199,"type":19},"2025-11-30",{"name":201,"class":39},"University of Alicante"]