[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diet-healthy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diet-healthy":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,46,79,106,132,159,184,206,229,260,290,310,336,361,388,416,448,474,511,544,570,595,624,654,677],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100578685","delivering-hope-helping-women-optimize-prenatal-equity-100578685",false,"NCT06814509","Delivering HOPE (Helping Women Optimize Prenatal Equity)","Inclusion Criteria:\n\n* Aged 16-44 years\n* ≤18 weeks pregnant\n* Speak English, Spanish, or Marshallese\n* Valid email address",true,"FEMALE","16 Years","44 Years",{"count":21,"type":22},1440,"ESTIMATED","INTERVENTIONAL",[25],"NA","The overarching research question is: \"Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?\" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000\u002F$2000\u002F$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.",[28,29,30,31,32],"Gestational Weight Gain","Diet, Healthy","Gestational Hypertension","Gestational Diabetes","Pregnancy Complications","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2025-06-24",{"date":41,"type":22},"2029-12-31",{"name":43,"class":44},"University of Arkansas","OTHER",8,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100638376","support-your-heart-phase-1-100638376","NCT07623733","Support Your Heart, Phase 1","Support Your Heart: Feasibility Trial of a Cardiovascular Health Intervention for Young Adults, Phase 1","SYH","Inclusion Criteria:\n\n1. 18-39 at time of enrollment\n2. Living in Washington DC area\n3. At least two risk factors for cardiovascular disease:\n\n   1. not enough sleep\n   2. insufficient physical activity\n   3. tobacco and nicotine product use\n   4. elevated body mass index\n   5. poor diet\n   6. high cholesterol\n   7. high blood pressure; and\u002For\n   8. elevated HbA1c.\n\nExclusion Criteria:\n\n* 1\\. Major medical condition or chronic disease that would impede physical activity or increase the risk of the intervention (e.g., reported type 1 or type 2 diabetes, cerebrovascular accident, systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>105 mmHg, renal disease, pulmonary disease dependent on oxygen, recent orthopedic injury, significant surgery within the last 6 months, HbA1c \\>6.5%, total cholesterol \\>240 mg\u002FdL); 2. Plan to become pregnant during study duration; 3. Psychiatric hospitalization, psychosis or suicide attempt within the last 12 months; 4. Alcohol or substance use disorder; 5. An eating disorder; 6. Conditions or behaviors that are likely to interfere with the conduct of the trial (e.g., inability to communicate with study staff, unwillingness to accept any of the three treatment assignments by randomization, current participation in another physical activity or lifestyle intervention research program)","ALL","18 Years","39 Years",{"count":58,"type":22},20,[25],"This is a pilot feasibility study designed to establish the feasibility and acceptability of the \"Support Your Heart\" (SYH) study's phone-based protocols regarding AHA's LE8, social isolation, loneliness, and stress.\n\nThe age range for this intervention is 18-39, which is intended to reflect the transitional life period from adolescence to adulthood. Participants must also display at least two LE8 risk factors for cardiovascular disease (e.g., not enough sleep or physical activity; tobacco\u002Fnicotine product use; elevated body mass index; high cholesterol, high blood pressure, elevated HbA1c , and\u002For poor diet).\n\nParticipants will receive weekly calls (averaging around 20-30 minutes each) from a SYH health coach in order to review key concepts, give personalized progress, and provide consistent feedback over the course of 12 weeks. SYH staff will measure improvement in AHA metrics as well as participant burden, acceptability, satisfaction, adherence, and retention. This research has the potential to create substantial public health impact by addressing cardiovascular health, social isolation, loneliness, and stress, all of which represent significant burdens to individual health.",[62,63,64,65,29,66],"Cardio Vascular Disease","Obesity & Overweight","Physical Activity","Sleep","Nicotine",[68],"Life's Essential 8","2026-05-28",{"date":71,"type":37},"2026-06-03",{"date":73,"type":22},"2026-06-01",{"date":75,"type":22},"2026-10-01",{"name":77,"class":44},"George Washington University",1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":16,"sex":54,"minAge":55,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100636360","investigating-the-bioavailability-of-broccoli-extract-supplements-100636360","NCT07564674","Investigating the Bioavailability of Broccoli Extract Supplements","Inclusion Criteria:\n\n* Healthy adults, 18-60 years of age\n* Willing to stop taking herbal and phytochemical (plant-based extract or phytochemical) supplements for 1 week prior to and during each study cycle\n* Willing to stop cruciferous vegetable intake 1 week prior to and during each study cycle\n* Must be able to give written informed consent\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) \\\u003C18.5 or \\>30.0 kg\u002Fm2\n* Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past three months\n* Pregnancy, breastfeeding, or planning to become pregnant before completing the study\n* Engaging in vigorous exercise more than 7 hours per week\n* Have a significant acute or chronic illness such as cardiovascular disease, kidney or liver disease, diabetes, thyroid disorder, or radiation or chemotherapy treatment for cancer within the past five years\n* Use of medications to control cholesterol (e.g. statins, cholestyramine) or fat absorption (e.g. orlistat)\n* Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedure (e.g. cholecystectomy) or disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis)\n* Allergic to broccoli, moringa, mustard, or maitake mushrooms\n* Weighs less than 110 pounds\n* Diagnosis of sickle cell disease","60 Years",{"count":87,"type":22},12,[25],"The goal of this clinical trial is to compare how much glucoraphanin and sulforaphane from 3 different versions of broccoli extract supplements is absorbed into the body and excreted in urine. This study involves generally healthy adults age 18-60 years. The supplements contain glucoraphanin and myrosinase enzyme, both naturally occurring in cruciferous vegetables. Once ingested, glucoraphanin is converted to the bioactive compound sulforaphane, which is thought to have numerous health benefits, including cancer prevention.\n\nParticipants will:\n\n* consume 3 different versions of broccoli extract supplements (glucoraphanin will range from 35-70 mg)\n* complete 3 separate 24 hour study cycles\n* submit blood and urine samples for 24 hours\n* follow diet restrictions (no cruciferous vegetables or condiments or phytochemical\u002Fherbal supplements for 1 week prior to and during each study cycle)",[29],[92,93,94,95],"cruciferous vegetable","broccoli extract supplement","glucoraphanin","sulforaphane","NOT_YET_RECRUITING","2026-05-01",{"date":99,"type":37},"2026-05-07",{"date":101,"type":22},"2026-09",{"date":103,"type":22},"2028-09",{"name":105,"class":44},"Oregon State University",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":16,"sex":54,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100559513","the-sleep2bwell-trial-100559513","NCT06565104","The Sleep2BWell Trial","Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion: The Sleep2BWell Community-Based Trial","Inclusion Criteria:\n\n1. English- and\u002For Spanish-speaking\n2. aged ≥20 years\n3. having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)\n\nExclusion Criteria:\n\n1. No known medical conditions that would prevent them from safely participating in the trial (e.g., neurological degenerative disease such as Parkinsons, severe psychiatric disorders, substance use disorder)\n2. History of cardiovascular disease or cancer\n3. Pregnant or desire to become pregnant during the study\n4. Less than one year postpartum","20 Years",{"count":115,"type":22},150,[25],"Improving multiple domains of cardiometabolic health (CMH) through contextual behavioral interventions has the potential to substantially reduce persistent chronic disease disparities. Sleep is critical for preserving CMH and is amenable to intervention in real-world settings. Although sleep health, in conjunction with other lifestyle behaviors, can improve CMH through complementary or synergistic pathways, most existing lifestyle change programs focus solely on diet and physical activity. Sleep2BWell is a community-based cluster randomized trial aimed at evaluating the impact of incorporating a multidimensional sleep health intervention into the BWell4Life program, an ongoing 4-week program for promoting CMH through healthy diet and physical activity, delivered by peer health educators at faith-based organizations and community centers in underserved NYC neighborhoods. The enhanced 6-week intervention, Sleep2BWell, will include the following additional components: 1) two sleep health education and group coaching sessions, 2) self-monitoring and motivational enhancement using a Fitbit, and 3) addressing prevalent environmental barriers to healthy sleep in urban settings such as noise and light with a novel and timely extension to address indoor air pollution. A total of 10 community sites will receive the intervention enrolling an average of 15 participants per site for an expected sample of 150. The investigators will collect objective measures of sleep and physical activity throughout the study, and assess diet and CMH outcomes at baseline and 10 weeks (primary endpoint). The investigators hypothesize that Sleep2BWell will improve CMH, including reduced blood pressure (primary outcome) improved health behaviors (sleep, diet, physical activity) and adiposity markers (secondary outcomes). To ensure the successful completion and future expansion of this work, this study will use mixed methods to understand implementation determinants and outcomes, guided by implementation science frameworks. This first-of-its-kind effectiveness-implementation study, addressing individual level behaviors and factors and upstream influences and leveraging key behavior change and community engagement strategies, will investigate the integration of sleep health into a multi-behavior lifestyle change intervention aimed at addressing CMH disparities in community settings. This innovative multilevel intervention will inform scalable sustainable community health approaches and public health policy to improve sleep health and CMH disparities through advancement in novel multilevel bundled behavioral interventions.",[119,120,29,64,121],"Blood Pressure","Sleep Health","Weight Loss","2026-04-10",{"date":124,"type":37},"2026-04-14",{"date":126,"type":37},"2025-01-25",{"date":128,"type":22},"2027-06",{"name":130,"class":44},"Columbia University",2,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":16,"sex":54,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":78},"100553682","efficacy-trial-of-healthy-together-juntos-100553682","NCT06489262","Efficacy Trial of Healthy Together (\"Juntos\")","Efficacy Trial of Healthy Together \"Juntos\": A Family-based Digital Lifestyle Intervention for Hispanic Adolescents and Their Parents","Inclusion Criteria:\n\nAdolescent\n\n1. Lives with participating biological parent or legal guardian;\n2. Self-identifies as Hispanic;\n3. Is between the ages of 12-15years old;\n4. Has access to a smartphone;\n5. Does not meet recommendations for physical activity as determined by a validated 2-item screener;\n6. Does not meet recommendations for daily fruit and vegetable intake (proxy for diet quality) as determined by a validated 2-item screener;\n7. Exceeds recommendations for screen time (proxy for sedentary behavior) as determined by a validated 6-item screener\n\nParent\n\n1. Is the biological parent or legal guardian of and lives with the adolescent;\n2. Self-identifies as Hispanic;\n3. Has access to a smartphone;\n\nExclusion Criteria:\n\nAdolescent\n\n1. Has BMI \\\u003C5th (underweight) or ≥95th percentile (obesity);\n2. Has a parent-reported chronic medical condition (e.g., type 2 diabetes) that requires more intensive intervention;\n3. Has parent-reported responses on a physical activity readiness questionnaire (PAR-Q) that indicates a serious health issue, and a physician does not approve participation;\n4. Has a parent-reported cognitive or developmental delay (e.g., Down Syndrome) that may interfere with understanding program materials.\n\nParent\n\n1. Provides PAR-Q responses that indicate a serious health issue and a physician does not approve participation;\n2. Reports family plans to move out of South Florida during the study follow-up period","12 Years","15 Years",{"count":142,"type":22},750,[25],"The purpose of this study is to assess the efficacy of a family-based digital (web and mobile phone-based) program known as Healthy Together (\"Juntos\") in preventing increases in body mass index and improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among Hispanic adolescents.",[146,147,29],"Obesity","Activity, Motor",[149],"Hispanic, family, digital health, obesity prevention, physical activity, nutrition","2026-03-19",{"date":152,"type":37},"2026-03-23",{"date":154,"type":37},"2025-02-28",{"date":156,"type":22},"2029-05-31",{"name":158,"class":44},"University of Miami",{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":54,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":78},"100532002","microbiome-and-diet-in-parkinsons-disease-100532002","NCT06207136","Microbiome and Diet in Parkinson's Disease","Canadian Parkinson's Microbiome Initiative: A Pilot Phase 2 Feasibility Randomized Controlled Trial of the MIND Diet in Parkinson's Disease","PD-Diet","Inclusion Criteria:\n\nEligible if the person living with Parkinson's has\u002Fis:\n\n1. a clinical diagnosis of PD,\n2. cognitively stable (no clinical dementia),\n3. between 40-80 years old,\n4. able to travel to UBC for 6 onsite visits over 18 months,\n5. sufficient English proficiency (coaching and cooking classes are in English only),\n6. on a stable dopaminergic medication for at least one month before baseline,\n7. computer and internet access at home, and can be available via video link for at least 80% of the study sessions.\n\nExclusion Criteria:\n\nNot eligible, if person has\u002Fis:\n\n1. a diagnosis of atypical parkinsonism,\n2. medical or psychiatric conditions that would prevent full participation in the nutrition intervention (such as food allergies), significant dysphagia, diabetes on insulin, anti-coagulation on warfarin, and inflammatory bowel disease,\n3. clinical dementia,\n4. unable to complete questionnaires or understand study instructions,\n5. using of immunomodulatory agents,\n6. used Probiotics in the last 4 weeks prior to study start,\n7. used Antibiotics in the last 3 months prior to study start,\n8. contraindications for MRI.","40 Years","80 Years",{"count":170,"type":22},40,[25],"The goal of this pilot study is to examine the feasibility and effects of an 18-month intervention diet compared to an active control diet (standard diet) in those living with Parkinson's Disease (PD), without dementia.\n\nResearch has shown that eating components of Mediterranean diets are associated with a 30% lower risk to develop PD and a 40% lower mortality rate in those living with PD. Diet may influence the gut and microbiomes, thus may affect PD risk and progression.\n\nThis study will examine how easy it will be to adhere to a certain type of diet for 18 months and what changes may occur in the gut microbiome and in PD symptoms on a specific diet during that time.\n\nThe study will involve in-person study visits at UBC as well as online diet coaching sessions and online group cooking classes over Zoom.\n\nThis is a randomized study, meaning that participants will be assigned by chance to either the Mediterranean-style diet group or the standard diet group for the duration of the 18 months.\n\nThis pilot study will also examine recruitment rates and retention, in order to prepare for a larger future study.",[174,29,175,176],"Parkinson Disease","Gut Microbiome","Gastrointestinal Microbiome",{"date":152,"type":37},{"date":179,"type":37},"2024-12-03",{"date":181,"type":22},"2027-12-31",{"name":183,"class":44},"University of British Columbia",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":54,"minAge":190,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":78},"100551777","whole-foods-for-teens-a-pilot-dietary-intervention-to-reduce-body-adiposity-in-adolescents-with-obesity-100551777","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;","10 Years",{"count":192,"type":22},60,[25],"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.",[196,29,197],"Obesity, Childhood","Body Weight Changes","2026-03-18",{"date":152,"type":37},{"date":201,"type":37},"2025-03-24",{"date":203,"type":22},"2027-04-30",{"name":205,"class":44},"Vanderbilt University",{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":54,"minAge":212,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":78},"100553196","whole-food-for-families-a-pilot-rct-of-a-dietary-guidelines-based-intervention-to-prevent-type-2-diabetes-100553196","NCT06482944","Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes","Inclusion Criteria:\n\nFor this study, eligible adults will be those that:\n\n1. are 25 to 59 years of age at time of initial screen and identify as a parent to at least one child or adolescent 6-18 years;\n2. have a body mass index of between ≥23kg\u002Fm2 to \\\u003C40kg\u002Fm2;\n3. have prediabetes (based on American Diabetes Association criteria of either fasting plasma glucose of ≥100 mg\u002FdL, HgbA1c 5.7-6.4%, or 2-hour plasma glucose during 75-g oral glucose tolerance test \\[OGTT\\] 140 mg\u002FdL to 199 mg\u002FdL) with recent lab values reported within the prior 6-12 months and confirmed by an HbA1c A1cNow+ collected prior to enrollment (\\*see comment below);\n4. have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods\u002Fbeverages;\n5. are English speaking;\n6. reside in Greater Nashville Tennessee and willing to come to Vanderbilt campus and Vanderbilt University Medical Center for required study visits;\n7. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);\n8. are able to participate in a 12-week dietary program that requires home preparation\u002Fcooking for meals and snacks;\n\nFor this study, eligible offspring will be those that:\n\n1. Are 6-18 years at time of initial screen;\n2. Have an index parent with prediabetes that is actively enrolled in the program;\n3. have body mass index ≥5th percentile for age and gender on standardized CDC growth curves;\n4. have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods\u002Fbeverages;\n5. have parental commitment to participate in a 12-week research study\n6. are English speaking;\n7. reside in the Greater Nashville Tennessee area and live at home with their index parent during the duration of 12- week study;\n8. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);\n9. are able to participate in a 12-week dietary program that includes at least dinner and snacks provided during after-school hours;\n\nExclusion Criteria:\n\nAdult exclusion criteria include:\n\n1. Adults who's HbA1c test is outside of the HbA1c range during screening\\* (see details related to screening results)\n2. adults outside the specified age range of \\\u003C25 years or \\>59 years;\n3. adults whose body mass index is \\\u003C23kg\u002Fm2 or those with a body mass index ≥40kg\u002Fm2 as that degree of morbid obesity represents a different phenotype where dietary behavioral intervention alone may not be sufficient to achieve weight loss);\n4. receiving care by a healthcare provider (i.e., MD, NP, PA) for a complicated diagnosis of prediabetes that requires routine glycemic monitoring or frequent healthcare visits for management\u002Ftreatment;\n5. adults actively participating in any type of weight loss program (dietary or physical activity)\n6. adults with a prior history of type 2 diabetes;\n7. adults who are not English speaking or have limited English-language proficiency;\n8. adults with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n9. adults with serious mental or neurologic illness that impairs the ability to consent\u002Fparticipate;\n10. women who are pregnant or nursing due to increased metabolic state requiring greater energy requirements;\n11. adults currently taking medications to treat diabetes or to promote weight loss;\n12. adults living outside Greater Nashville Tennessee or who are unwilling to travel to Vanderbilt for study visits;\n13. adults who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;\n\nOffspring (child\\[ren\\] and adolescent\\[s\\]) exclusion criteria include:\n\n1. children\u002Fadolescents outside the specified age range of \\\u003C6 years or \\>18 years;\n2. children\u002Fadolescents whose body mass index is \\\u003C5th percentile for age and gender on standardized CDC growth curves;\n3. children\u002Fadolescents who do not have an eligible index parent participating in the study;\n4. children who do not have parental commitment to participate consistently for 12-weeks\n5. children\u002Fadolescents who are not English speaking or have limited English-language proficiency;\n6. children\u002Fadolescents with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n7. children\u002Fadolescents who display dissenting behaviors during baseline data collection;\n8. children\u002Fadolescents actively participating in any type of weight loss program (medical or lifestyle);\n9. children\u002Fadolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;","6 Years","59 Years",{"count":215,"type":22},30,[25],"This study will address the following aims:\n\nAim 1 (primary): Conduct a pilot RCT to evaluate the feasibility, acceptability, enrollment, and retention rates of adult-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet.\n\nFeasibility: ≥80% participant retention and completion of study outcome measures.\n\nAcceptability: ≥75 adult diet satisfaction via survey report and\u002For perceived diet satisfaction via focus groups. Aim 2: Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adult\u002Fchild diet quality during the 12-week intervention.\n\nAim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes.\n\nHypothesis 2a: Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group.\n\nAim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and children. Hypothesis 2b: Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group.\n\nAim 3: Conduct family focus groups to understand how SDOH and individual\u002Ffamily needs and preferences may be perceived barriers or facilitators of diet adherence.",[219,29,220],"PreDiabetes","Nutritional and Metabolic Diseases","2026-03-05",{"date":223,"type":37},"2026-03-06",{"date":225,"type":37},"2025-10-13",{"date":227,"type":22},"2027-06-30",{"name":205,"class":44},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":236,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":78},"100494730","with-love-grandma-con-cario-abuelita-pilot-study-100494730","NCT05721976","With Love, Grandma (\"Con Cariño, Abuelita\") Pilot Study","Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families","Cancer Survivor Inclusion Criteria:\n\n* Grandmother\n* Self-identifies as Hispanic\n* Diagnosis of breast cancer (stages I-III), endometrial or ovarian cancer (stages I-II)\n* Completed active treatment (i.e., surgery, chemotherapy, and\u002For radiation)\n* Body Mass Index (BMI) ≥ 25 (overweight range)\n* Engages in \\\u003C150 minutes\u002Fweek of moderate physical activity\n* English or Spanish speaking\n* Owns a mobile device with internet access (e.g., smartphone, tablet)\n* Lives in South Florida\n\nDaughter of Cancer Survivor Inclusion Criteria:\n\n* Adult daughter of the identified cancer survivor (21 years of age or older)\n* Has at least 1 living child ages ≤16 years old\n* Body Mass Index (BMI) ≥ 25 (overweight range) OR engages in \\\u003C150 minutes\u002Fweek of moderate physical activity\n* English or Spanish speaking\n* Owns a mobile device with internet access (e.g., smartphone, tablet)\n* Lives in South Florida\n\nDaughter of Cancer Survivor Exclusion Criteria:\n\n* Has been diagnosed with distant metastatic cancer\n* Has not completed active treatment (i.e., surgery, chemotherapy, and\u002For radiation)\n* Has uncontrolled schizophrenia or bipolar disorder\n* Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions,wheelchair bound).\n\nCancer Survivor Exclusion Criteria:\n\n* Has uncontrolled schizophrenia or bipolar disorder\n* Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions, wheelchair bound)","21 Years",{"count":192,"type":22},[25],"The purpose of this study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile-phone-based) program to improve lifestyle behaviors (physical activity, dietary intake) among Hispanic female cancer survivors and adult daughters.",[241,242,243,146,147,29],"Cancer, Breast","Cancer, Uterus","Cancer, Ovary",[245,246,247,248,249,250],"Hispanic","family","digital health","cancer survivorship","physical activity","nutrition","2026-02-24",{"date":253,"type":37},"2026-02-25",{"date":255,"type":37},"2023-02-22",{"date":257,"type":22},"2026-12-31",{"name":259,"class":44},"University of Miami Sylvester Comprehensive Cancer Center",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":267,"enrollmentInfo":268,"targetDuration":270,"studyType":271,"phases":4,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100618312","fear-of-hypoglycemia-in-patients-with-diabetes-100618312","NCT07329985","FEAR of HYPOGLYCEMIA in PATIENTS WITH DIABETES","THE EFFECT OF FEAR OF HYPOGLYCEMIA ON DIET AND MEDICATION ADHERENCE IN PATIENTS WITH DIABETES","Inclusion Criteria:\n\nDiagnosed with diabetes Aged 18-65 Having experienced at least one hypoglycemic attack previously, Using antidiabetic medication (oral pills and\u002For insulin), Volunteered to participate in the study\n\nExclusion Criteria:\n\nunable to communicate in the same language having cognitive impairment wanting to leave the study at any stage","65 Years",{"count":269,"type":22},100,"1 Day","OBSERVATIONAL","Fear of hypoglycemia has a significant impact on both medication and dietary adherence in individuals with diabetes. Through avoidance behaviors, it can disrupt metabolic control, prevent the achievement of glycemic targets, and increase the risk of long-term complications. Therefore, monitoring only biochemical parameters is insufficient in diabetes management. It is crucial for healthcare professionals to systematically assess the fear of hypoglycemia.",[274,29,275,276],"Diabetes Mellitus","Medication Adherence","Hypoglycemia",[278,275,279,280],"Diabetes","Nursing","Diet","2026-02-19",{"date":283,"type":37},"2026-02-20",{"date":285,"type":22},"2026-04-15",{"date":287,"type":22},"2026-12-15",{"name":289,"class":44},"Bilecik Seyh Edebali Universitesi",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":308,"locationsCount":78},"100571095","feast-perinatal-support-program-intervention-100571095","NCT06715787","FEAST Perinatal Support Program Intervention","Evaluating the Food Education Access Support Together (FEAST) Perinatal Support Program: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Currently pregnant\n* Speak and read English\n* Eligible for Electronics Benefit Transfer (EBT) and\u002For Women, Infants, and Children (WIC) benefits\n\nExclusion Criteria:\n\n* Inability to attend in-person sessions",{"count":170,"type":22},[25],"Latino individuals face an elevated risk of adverse health outcomes during pregnancy, impacting both the birthing parent and the baby with potential long-term chronic health conditions. While promoting a healthy diet during pregnancy is a promising strategy, interventions targeting dietary behaviors have yielded mixed results and lack widespread dissemination in communities in need. Collaborating with community-based organizations could enhance cultural relevance, build trust with Latino families, and improve program reach and effectiveness. Food Education Access Support Together (FEAST) is a community-based program that promotes healthy eating, well-being, and health equity for diverse, under-resourced urban populations in Los Angeles. The newly developed FEAST Perinatal Support Program (PSP) aims to support individuals through pregnancy and postpartum by providing dietary psychoeducation, skill-building, and social support, with an additional component of grocery gift cards to address food access barriers. This study proposes a pilot trial to assess the feasibility and preliminary efficacy of the FEAST PSP in enhancing dietary outcomes, overall health, and socio-cognitive precursors, in pregnant individuals. The study will enroll 40 pregnant adults in a single-arm study who will receive the core PSP with a $15 gift card for healthful fresh food (PSP+giftcard). Pre- and post-intervention assessments will include questionnaires, dietary recalls, physical measurements, and interviews to evaluate program perceptions. Specific aims include evaluating program feasibility and acceptability (i.e., reach, retention, and participant perceptions) and determining preliminary efficacy on changing socio-cognitive and behavioral aspects of diet, self-reported health, and cardiometabolic risk factors. The project aligns with goals of improving health outcomes in Latino families in Southern California and supports FEAST's strategic objectives for improving health and wellness of individuals during pregnancy and throughout the lifespan. The findings will inform program refinement and future NIH grants for rigorous evaluation of the FEAST PSP.",[29,146,301],"Cardiometabolic Syndrome","2026-01-29",{"date":304,"type":37},"2026-02-02",{"date":306,"type":22},"2026-02",{"date":101,"type":22},{"name":309,"class":44},"University of Southern California",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":16,"sex":54,"minAge":317,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":131},"100524615","nurturing-needs-study-parenting-food-motivated-children-100524615","NCT06111040","Nurturing Needs Study: Parenting Food Motivated Children","Deconstructing Food Parenting Approaches to Obesity Prevention for the Highly Food Motivated Child","Inclusion Criteria:\n\n1. Child ages 4 or 5 years at baseline;\n2. Parent\u002F primary caregiver with legal representation (having 50% or more custody of child);\n3. Parent\u002Fprimary caregiver reporting primary responsibility for child feeding outside of childcare (being with child when they are eating at least two times daily);\n4. Caregiver with a cell phone that can be used to send and receive text messages. If there is more than one age-eligible child in the family, we will ask the caregiver to pick the index child.\n\nExclusion Criteria:\n\n1. Parent\u002Fprimary caregiver \\\u003C18 years of age;\n2. Child history of major food allergies (e.g., peanuts);\n3. Child medication use (e.g., insulin), developmental disability (e.g., autism) or medical condition(s) (e.g., diabetes) known to affect food intake and growth;\n4. Foster child.","4 Years","5 Years",{"count":320,"type":22},416,[25],"High food motivation among children is trait-like and increases risks of unhealthy dietary intake and obesity. Scientific knowledge of how parenting can best support healthy eating habits and growth among children who are predisposed to overeating is surprisingly limited. This investigation will identify supportive food parenting approaches for obesity prevention that address the needs of highly food motivated children.",[324,325,29,326],"Parenting","Eating Behavior","Pediatric Obesity","2025-11-03",{"date":329,"type":37},"2025-11-05",{"date":331,"type":37},"2023-09-07",{"date":333,"type":22},"2027-10-31",{"name":335,"class":44},"Temple University",{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":16,"sex":54,"minAge":343,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":78},"100609935","a-food-as-medicine-approach-to-address-food-insecurity-in-rural-north-carolina-100609935","NCT07221045","A Food As Medicine Approach to Address Food Insecurity in Rural North Carolina","PhytoRx Families: A Pilot Test Study to Address Food Security and Fruit and Vegetable Intake in Rural North Carolina","Inclusion Criteria:\n\n* Fluent in English or Spanish (speaking, reading, writing)\n* An adult (18 years of age or older) who's a parent or caregiver of a child ages 8 to 14 years old or a child ages 8 to 14 years old\n* Served at participating clinic in a county where the program is being implemented (Goldsboro Pediatrics, Bertie County Rural Health Association, and Roanoke Chowan Community Health in Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)\n* Living in a county where the program is being implemented (Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)\n* Free living to the extent they are able to receive and use a box of fresh produce and participate in direct nutrition education classes\n* Willing and able to provide written consent and participate in all study activities.\n\nExclusion Criteria:\n\n* Adults not at risk of food insecurity\n* Adults, who are not parents nor caregivers of a child 8 to 14 years\n* Adults who do not want to or could not fully participate (e.g., an adult family member with advanced kidney disease with severe dietary restrictions).","8 Years","64 Years",{"count":215,"type":22},[25],"Increasing fruit and vegetable (FV) intake, and reducing saturated fat, salt, and added sugar are central lifestyle recommendations in the Dietary Guidelines for Americans to prevent chronic disease. Yet, while diet is modifiable, numerous barriers exist for lower-resourced families to engage in healthy dietary behaviors. In particular, rural families face structural and systemic disparities, such as inadequate access to affordable healthy food. Thus, this project. Thus, this study, PhytoRx Families, an innovative produce prescription (Prx) program, addresses health disparities in rural North Carolina (NC). This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare utilization outcomes.",[29,349,119,350,351],"Health Behavior","Diabetes Mellitus Risk","Utilization, Health Care","2025-10-23",{"date":354,"type":37},"2025-10-27",{"date":356,"type":37},"2025-04-18",{"date":358,"type":22},"2026-05-31",{"name":360,"class":44},"North Carolina State University",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":367,"minAge":55,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":78},"100520320","black-impact-the-mechanisms-underlying-psychosocial-stress-reduction-in-a-cardiovascular-health-intervention-100520320","NCT06055036","Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention","Inclusion Criteria:\n\n* The inclusion criteria are: 1) Black men (self-report); 2) adult age 18 years or older; 3) Life's Essential 8 total average score \\\u003C 80; 4) English speaking; and 5) lives in Metropolitan Columbus, Ohio.\n\nExclusion Criteria:\n\n* healthcare provider-imposed limitations on physical activity.","MALE",{"count":369,"type":22},340,[25],"Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race\u002Fsex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\\\u003C4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\\\u003C0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.",[301,373,374,375,219,146,376,377,65,378,29,119],"Physical Inactivity","Hypertension","Type 2 Diabetes","Cardiovascular Diseases","Smoking","Hyperlipidemias","2025-09-30",{"date":381,"type":37},"2025-10-06",{"date":383,"type":37},"2023-08-24",{"date":385,"type":22},"2027-03-31",{"name":387,"class":44},"Ohio State University",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":267,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":402,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100434815","nutritional-impact-of-a-hypocaloric-hyperprotein-diet-before-obesity-surgery-100434815","NCT04942093","NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery","NUTRACOB","Inclusion Criteria:\n\n* Patient eligible for bariatric surgery (according to HAS criteria) whose sleeve gastrectomy is scheduled\n* Patient with morbid obesity (BMI ≥ 40)\n* Age ≥ 18 years and ≤ 65 years\n* Haemoglobinemia ≥ 12 g\u002FdL in men and ≥ 11 g\u002FdL in women\n* Patient speaking and understanding French\n* Adult having read and understood the information letter and signed the consent form\n* Woman of childbearing age with effective \u002F very effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) prior to surgery and a negative -HCG blood pregnancy test at inclusion, for the duration of the study\n* Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit)\n* Patient affiliated with, or beneficiary of a social security (health insurance) category\n\nExclusion Criteria:\n\n* Contraindication to bariatric surgery detected during the preoperative assessment\n* Medical contraindication to a restrictive diet\n* Type I or II insulin-requiring diabetes\n* Severe renal insufficiency defined by a blood filtration rate \\\u003C 30 mL\u002Fmin\n* Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.)\n* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection \u002F sub-guardianship or curatorship\n* A history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him\u002Fher from giving informed consent",{"count":396,"type":22},200,[25],"Obesity is a major public health problem and is constantly on the rise. Therapeutic approaches based on dietary advice, physical activity and the management of psychological difficulties are not always sufficient to achieve a lasting weight reduction.\n\nBariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders).\n\nThe surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load).\n\nFaced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success.",[29,400,401],"Obesity, Visceral","Bariatric Surgery Candidate",[403,404,405],"diet","obesity","bariatric surgery","2025-09-16",{"date":408,"type":37},"2025-09-22",{"date":410,"type":37},"2023-10-09",{"date":412,"type":22},"2027-03-20",{"name":414,"class":44},"University Hospital, Rouen",3,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":16,"sex":367,"minAge":113,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":271,"phases":4,"briefSummary":427,"conditions":428,"keywords":431,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":78},"100535522","diet-induced-changes-in-genetic-material-100535522","NCT06252922","Diet-Induced Changes in GEnetic Material","A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes","DIG 'EM","Inclusion Criteria:\n\n* Male based on biological sex\n* Age 20-35 years\n* BMI between 18.5 and 24.9 kg\u002Fm2\n* White\u002FCaucasian\n* Willing to consume pre-prepared meals\n* Willing to wear an accelerometer and continuous glucose monitor (CGM)\n* Willing to track diet intake\n* Willing to stay 24 hours, including overnight in a research clinic\n* Willing to provide blood and sperm samples\n* Willing to consent to whole-genome sequencing of DNA\n\nExclusion Criteria:\n\n* Unstable weight in the last 3 months (±5% weight loss or gain)\n* Shift work or working in a factory setting\n* Habitual smoking or use of tobacco products, including vaping, within the past 6 months.\n* History of clinically diagnosed diabetes\n* Hypertension (\\>140\u002F90 mmHg measured at screening)\n* Has undergone bariatric surgery\n* History of cardiovascular disease, neurological disease, or other chronic diseases, including cancer\n* History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)\n* Adherence to special or restrained diets (e.g., low-CHO, low-fat, or vegetarian\u002Fvegan diets) or food allergies associated with study foods.\n* Currently engaging in \\>150 minutes moderate-intensity or \\>75 minutes of vigorous-intensity physical activity each week\n* Drinking more than 14 servings of beer or alcohol per week\n* Depressive (Score ≥10), anxiety (Score ≥8), and stress (Score≥15) symptomology (Score ≥16) from the 42-item Depression, Anxiety, Stress Scales (DASS)","35 Years",{"count":426,"type":22},10,"This is a pilot study in 10 men to test the hypothesis that perturbations in substrate flux and the circulating metabolic and pro-inflammatory milieus during a high-fat diet paradigm will modulate DNA methylation of genes in sperm associated with obesity and cardiometabolic dysfunction.",[29,429,430],"Body Weight","Metabolic Disturbance",[432,433,434,435,436,437,438],"Healthy Weight","High-Fat Diet","Sperm DNA Methylation","Metabolic Flexibility","DNA Damage","Substrate Flux","Preconception","2025-05-27",{"date":441,"type":37},"2025-05-31",{"date":443,"type":37},"2023-11-11",{"date":445,"type":22},"2026-12-30",{"name":447,"class":44},"Pennington Biomedical Research Center",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":16,"sex":54,"minAge":318,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":463,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":78},"100454378","maximizing-nutrition-education-to-meet-dietary-and-food-security-of-children-and-parents-100454378","NCT05196763","Maximizing Nutrition Education to Meet Dietary and Food Security of Children and Parents","Maximizing the Impact of Nutrition Education to Meet the Dietary Quality and Food Security Needs of Children and Parents","Inclusion Criteria:\n\n* households in Indiana\n* households with children\n* English speaking\n* eligible to receive SNAP (≥18 years and household income at or below 130% of the poverty guideline)\n* willing to allow a child 5-18 years to participate\n* willing to participate in the study and wait 1 year to receive SNAP-Ed\n\nExclusion Criteria:\n\n* not have received SNAP-Ed lessons in the past year\n* not pregnant or lactating (due to inherent dietary changes)",{"count":456,"type":22},300,[25],"Food insecurity and low diet quality are persistent problems linked with chronic disease and poor health among limited-resource children and adults using Supplemental Nutrition Assistance Program (SNAP). We have shown nutrition education via adult-focused, direct SNAP-Education (SNAP-Ed) improved household food security by 25% but not adult dietary quality among SNAP-eligible households using a randomized, controlled, longitudinal SNAP-Ed intervention in Indiana. Households experiencing food insecurity often reserve food considered \"healthful\" for children, so child dietary quality improvement may precede that observed among adults when household food security improves. This study will determine the effect of adult-focused direct SNAP-Ed on child dietary quality and household food security using a longitudinal randomized, controlled SNAP-Ed intervention. Assessment will include repeated 24-hour dietary recalls to determine usual intake, the U.S. Household Food Security Survey Module, and behavior data from before and after the 10-week \"intervention period,\" and 1 year later, after which the control group will receive the intervention. Low-income participants (n=275) from Indiana will be recruited following SNAP-Ed protocol. Results of the study will inform the creation of supplementary on-demand SNAP-Ed educational material focused on improving healthful dietary intake for children and adults in situations of food insecurity in households with children. Education on modeling healthy attitudes and behaviors, planning and preparing family meals, and dietary shortfalls as informed by the results and previous evidence will be included and evaluated. The study aligns with the goals of USDA to increase food security and this RFP to improve healthful behaviors, food quality and nutrition.",[460,461,29,462],"Nutrition, Healthy","Hunger","Food Habits",[464,465,466,250],"food security","food insecurity","dietary quality",{"date":441,"type":37},{"date":469,"type":37},"2022-11-01",{"date":471,"type":22},"2027-12",{"name":473,"class":44},"Purdue University",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":16,"sex":54,"minAge":55,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":493,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":78},"100590898","the-switch-dietary-and-behavioural-intervention-study-100590898","NCT06973408","The SWITCH Dietary and Behavioural Intervention Study","Switching to a Healthy and Sustainable Diet for Planetary and Human Health","SWITCH","Inclusion Criteria:\n\n* Age 18-70 years\n* Body mass index 25-35 kg\u002Fm2\n* Stable dietary patterns at the entry to the study (no specific dieting the last 4 weeks).\n* Willingness to adhere to advised diet pattern and to consume provided key foods.\n* Medications stable for the previous 14 days of relevant medicines\n* Access to a -18⁰ C freezer to store key foods at home.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Currently having an infection or other relevant illness.\n* Cardiovascular events (myocardial infarction or stroke) during the previous 6 months. To be included, the disease needs to be stable.\n* Diagnosis of diabetes (any type).\n* Blood Pressure (BP): ≥185\u002F105 mmHg.\n* Serum Cholesterol (S-Chol): ≥8 mmol\u002FL.\n* Blood Glucose (B-Glucose): fasting value \\>7 mmol\u002FL.\n* Currently on GLP-1 receptor agonists.\n* History of stomach or gastrointestinal diagnoses (inflammatory bowel disease, Crohn's disease, hepatitis, malabsorption, celiac disease etc.).\n* IBS- if severe and recent (\\\u003C0.5year)?\n* Previous colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery.\n* Renal or liver failure (creatinine \\\u003C1.7 mg\u002Fdl and alanine aminotransferase\u002F aspartate aminotransferase \\> 2 times than normal values (ASAT, ALAT), respectively).\n* Anemia or Hemoglobin (Hb): \\\u003C100 g\u002FL\n* Blood donation (or participation in a clinical study with blood sampling) within 30 days prior to inclusion\n* Currently on a specific diet.\n* A diet incompatible with protocol diets such as strict vegan\u002Fvegetarian.\n* Food allergies or intolerances to food items included in the intervention.\n* High level of regular physical activity at baseline - scale 4 on SG-PALS.\n* History of drug or alcohol abuse.\n* Not able to understand written or spoken Swedish.\n* Any other reason for lack of suitability for participation in the trial, as judged by the principal investor and\u002F or the clinical investigator.\n* Pregnant or lactating or planning to become pregnant during the study period.\n* Involved in another potentially interfering research study.","70 Years",{"count":456,"type":22},[25],"The overall objective of this study is to evaluate the effectiveness of an optimized lifestyle intervention based on dietary advice, behavioral support, and provision of key foods compared to dietary advice with behavioral support or dietary advice alone. The intervention aims to improve nutritional status, metabolic risk factors, and planetary sustainability.\n\nA total of 300 participants (150 men and 150 women) who meet all inclusion criteria and none of the exclusion criteria will be recruited. The study will be conducted at the Centre for Lifestyle Intervention at Östra Hospital in Gothenburg, led by researchers from Chalmers University of Technology, University of Gothenburg, and Sahlgrenska University Hospital. Participants will be recruited from two different socioeconomic areas in Gothenburg to examine how dietary interventions function in diverse population groups.\n\nThe study follows a twelve-week randomized, controlled, parallel intervention design. Participants will be randomized into three groups, each with 100 individuals:\n\nOptimized lifestyle intervention group - receiving dietary advice, behavioral support, and provision of key foods.\n\nBehavioral support intervention group - receiving dietary advice and behavioral support.\n\nControl group - receiving dietary advice according to the SWITCH diet. The SWITCH diet, developed within the EU project SWITCH, is designed to align with European dietary guidelines and promote sustainable and healthy eating habits. It emphasizes whole grains, vegetables, fruits, legumes, and sustainable seafood while limiting processed foods, added sugars, and salt.\n\nThroughout the study, participants will undergo clinical assessments at baseline, midpoint (week 7), and endpoint (week 13). Key measurements include anthropometric data, blood pressure, blood glucose, blood lipids, and inflammatory markers. Dietary intake and sustainability aspects of food consumption will also be evaluated. Participants in the intervention groups will receive personalized coaching and access to practical resources, such as meal plans, recipes, and visual educational materials.\n\nThe primary outcome of the study is the difference in cardiometabolic risk factors (e.g., blood lipids, blood pressure, glucose, insulin resistance markers) between the intervention groups. Secondary outcomes include changes in dietary intake, nutritional status markers, inflammatory markers, and sustainability measures (e.g., CO₂ emissions, land use, biodiversity impact). Additionally, exploratory analyses will investigate associations between diet, lifestyle changes, gut microbiota, and metabolic responses.\n\nThis study aims to generate valuable insights into the effectiveness of different dietary intervention strategies in real-life Nordic conditions. The results will contribute to the development of evidence-based recommendations for sustainable and health-promoting dietary patterns.",[487,488,489,490,491,492,29],"Dietary Behaviour","Dietary Intakes","Dietary Intervention","Metabolic Diseases","Blood Lipid Profiles","Blood Glucose Metabolism",[494,495,496,497,498,499,500,501],"Cardiometabolic health","Lifestyle intervention","Dietary adherence","Sustainable diet","Nordic diet","Metabolic risk factors","Randomized controlled trial","nevironmental impact of diet","2025-05-14",{"date":504,"type":37},"2025-05-15",{"date":506,"type":37},"2025-03-03",{"date":508,"type":22},"2026-11-30",{"name":510,"class":44},"Chalmers University of Technology",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":16,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":78},"100523714","strong-families-start-at-homefamilias-fuertes-comienzan-en-casa-100523714","NCT06099288","Strong Families Start at Home\u002FFamilias Fuertes Comienzan en Casa","Strong Families Start at Home\u002FFamilias Fuertes Comienzan en Casa: A Novel Video and Motivational Interviewing Intervention to Improve Diet Quality of Low-income, Ethnically Diverse Children","Inclusion Criteria:\n\n* At least 18 years old\n* Self-identity as Latinx\u002FHispanic\n* Speak English or Spanish\n* Be the primary caregiver of a child between 2- 5 years of age\n* Live with the child most of the time\n* Eat a minimum of three evening meals per week with the child\n* Not have participated in the R34 study\n* Have a smart phone\n* Be willing to have a meal video recorded in the home\n\nExclusion Criteria:\n\n* A doctor or WIC provider has told them that their child was underweight in the past 6 months\n* The child has a diagnosed feeding disorder or dietary restriction that impacts how they eat",{"count":519,"type":22},257,[25],"The goal of this clinical trial is to test the ability of a home-based parental nutrition intervention to improve diet quality in preschool aged children within low-income, Latinx\u002FHispanic families. The main questions it aims to answer are:\n\n* Does this enhanced intervention change children's diet quality?\n* Does this enhanced intervention change parental feeding practices?\n* Does this enhanced intervention change the availability of healthy foods in the home?\n\nParticipants will:\n\n* Work with a support coach\n* Have a home visit with a support coach once a month, for three months\n* Have a phone call with a support coach once a month, for three months\n* Receive written materials and text messages over the six months\n\nResearchers will compare a control group receiving different written materials and messages to see if the enhanced intervention changes diet quality in children.",[523,29],"Metabolic Syndrome, Protection Against",[525,526,527,528,529,530,531,532,533,534],"Motivational Interview","Home-Based","Intervention","Latinx","Families","Nutrition","Cultural Tailoring","Social Cognitive Theory","Self-Determination Theory","Self-Perception Theory","2025-05-06",{"date":537,"type":37},"2025-05-07",{"date":539,"type":37},"2024-01-01",{"date":541,"type":22},"2027-11-01",{"name":543,"class":44},"Brown University",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":16,"sex":54,"minAge":55,"maxAge":552,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":78},"100539008","behavioral-economics-to-implement-a-traffic-light-nutrition-ranking-system-study-2-100539008","NCT06298253","Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2","Behavioral Economics to Implement a Traffic Light Nutrition Ranking System in a Network of Food Pantries: Study 2","BeWell","Inclusion Criteria:\n\n* Food pantries enrolled in the study will be partner agencies of the Greater Boston Food Bank that are maximum client choice, are located within approximately 1 hour driving time of Boston (for logistical feasibility), and are not actively using traffic-light nutrition ranking.\n* Food pantry clients that complete assessments must be 18 years or older and speak English or Spanish.\n\nExclusion Criteria:\n\n* Food pantries that are not affiliated with the Greater Boston Food Bank and are not maximum client choice.\n* Food pantry clients that do not speak English or Spanish.","90 Years",{"count":554,"type":22},3750,[25],"This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries.",[558,559,29,560],"Food Insecurity","Implementation Science","Behavioral Economics","2025-04-27",{"date":563,"type":37},"2025-04-30",{"date":565,"type":37},"2024-10-01",{"date":567,"type":22},"2028-06",{"name":569,"class":44},"Massachusetts General Hospital",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":16,"sex":54,"minAge":578,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":23,"phases":581,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":78},"100463031","phase-3-food-prescriptions-to-promote-affordable-diets-100463031","NCT05309395","Food Prescriptions to Promote Affordable Diets","Food Prescriptions to Promote Affordable Diets That Meet RDAs Among Multi-generational Latino Households","FoodRx","Inclusion Criteria:\n\n* Multigenerational Latino household that has at least 2 adults with a BMI \\>27 kg\u002Fm2 and who both want to lose weight and at least one child under age 18; \\[Multi-generational is defined as having household members in two or three age groups: a) less than 18 years; b) 18-64 years; c) 65 years or older\\]; The household should have between 3-5 residents.\n* Owns at least 1 smart phone, tablet or computer or has internet access;\n* No dietary exclusions or medical conditions (e.g. chronic kidney disease, or using insulin (those with type 2 diabetes mellitus without needing insulin can participate)\n* Plans to stay in the area for 12 months;\n* Must not be using medications that interfere with weight loss (e.g., steroids, certain anti-depressants, anti-seizure medications),\n* Willing to pay for groceries\n* If on Calfresh, must be willing to pick up groceries at the store.\n\nExclusion Criteria:\n\n* Chronic kidney disease,\n* insulin dependent diabetes,\n* dietary exclusions that are inconsistent with menus","2 Years",{"count":580,"type":22},720,[582],"PHASE3","This is an Randomized controlled trial (RCT) to assess the impact of meal planning and affordable grocery delivery on weight loss, dietary quality and health on members of multigenerational Latino households.",[29,585],"Overweight and Obesity","2025-04-25",{"date":588,"type":37},"2025-04-29",{"date":590,"type":37},"2021-08-21",{"date":592,"type":22},"2027-06-01",{"name":594,"class":44},"Kaiser Permanente",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":54,"minAge":267,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":608,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":623},"100505122","therapeutic-fasting-and-immune-aging-100505122","NCT05857241","Therapeutic Fasting and Immune Aging","Therapeutic Fasting and Immune Aging: A Pilot Study of Tolerance","JÛVENILE","Inclusion Criteria :\n\n* Patient affiliated or entitled to a social security scheme\n* Residing in a Long-Term Care Unit (LTCU) or a Facility for the Elderly Dependent (EHPAD)\n* A person deemed a priori, by the geriatrician member of the monitoring committee, to be capable of following the dietary recommendations required for the study.\n* A person deemed a priori, by the clinician in charge, to be able to follow the dietary recommendations required by the study.\n* Patient who has received informed information about the study and has co-signed a consent to participate in the study with the investigator.\n\nExclusion Criteria :\n\n* Inability and\u002For unwillingness to follow dietary recommendations and\u002For perform follow-up examinations required for the study\n* Iso-resource group 1 or 2 according to the AGGIR grid\n* BMI \\\u003C 18.5 kg\u002Fm2 or recent weight loss \\> 5% in 1 month or recent weight loss \\> 10% in 6 months from previous weight\n* Albuminemia \\\u003C 30g\u002Fl\n* All swallowing disorders requiring a specific diet.\n* Influenza vaccination received prior to inclusion\n* Episode of influenza or suspected influenza during the 2020-2021 season and prior to inclusion\n* Any acute medical or surgical event less than 2 weeks prior to inclusion\n* Presence of systemic inflammatory or autoimmune disease\n* Presence of an innate or acquired immune deficiency (including taking immunosuppressive treatment)\n* Presence of a chronic disease which, according to the physician, makes the follow-up of a \"fasting diet\" and\u002For the consumption of large amounts of liquids (cf. fasting diet modalities) risky (e.g. insulin-dependent or insulin-requiring diabetes, severe heart failure, severe kidney failure, active cancer, significant undernutrition...) or impossible (e.g. advanced neurodegenerative pathology).",{"count":58,"type":22},[25],"Immunosenescence is the age-related decline of the immune system, involving a state of chronic inflammation and a decrease in the diversity\u002Fadaptability of the lymphocyte repertoire. The consequences of immunosenescence are multiple, including increased susceptibility to infections and poorer vaccine responses.",[607,29],"Fasting",[609,610,611,612,613],"Fasting mimicking diet","Aged","immunology","immunosenescence","tolerance","2025-04-07",{"date":616,"type":37},"2025-04-08",{"date":618,"type":22},"2025-04",{"date":620,"type":22},"2026-03",{"name":622,"class":44},"Centre Hospitalier Universitaire de Saint Etienne",5,{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":167,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":639,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":78},"100472475","esan-ii---energy-sensing-in-depression-100472475","NCT05432362","ESAN II - Energy Sensing in Depression","ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.","Inclusion Criteria:\n\n1. Socio-demographic criteria:\n\n   1. Gender: female\n   2. Age: 18-40 years\n2. Confirmation of the study settings\n\n   1. receives of information on\n\n      * the aims,\n      * methods,\n      * anticipated benefits,\n      * potential risks, and\n      * entailed discomforts of the study\n   2. signed declaration of consent\n3. Subgroup of depressive patients:\n\n   1. diagnosis of depression according to the ICD-10 criteria for depression\n   2. diagnosed by an experienced psychiatrist\n\n      * a structured diagnostic interview\n      * voluntarily agreement to participate\n      * signed informed consent\n4. Subgroup of normal weight participants:\n\n   * WHO criteria for normal weight (body mass index (BMI) 18.5-24.99 kg\u002Fm2)\n5. Subgroup of obese participants\n\n   * WHO criteria for obesity (BMI \\\u003C 30.0 kg\u002Fm2)\n\nExclusion Criteria:\n\n1. Formal criteria:\n\n   * lack of informed consent\n2. Health criteria\n\n   1. alcohol- or drug abuse\n   2. major cognitive deficits (which do not allow adequate testing)\n\n      * according to Mini Mental Status Examination (MMSE) \\\u003C20\n   3. patients which are currently in the locked ward of the clinic\n   4. acute or chronic diseases or infections within the previous two months\n\n      * upper respiratory tract infections\n      * fever\n      * chronic inflammatory disorders\n      * autoimmune-disorders\n      * blood diseases\n      * mitochondrial diseases\n3. Digestive disorders\n\n   1. fructose intolerance\n   2. history of digestive diseases such as\n\n      * inflammatory bowel disease\n      * irritable bowel syndrome\n   3. treatment that may has influenced the microbiome\n\n      * antibiotic or antifungal treatment within the previous two months\n      * daily or irregular intake of prebiotics or probiotics within the previous two months (the intake of yoghurt and dairy products are permitted)\n   4. history of gastrointestinal surgery (other than appendectomy)\n4. Pregnancy and period of breastfeeding",{"count":632,"type":22},120,[25],"The purpose of this study is to assess the effects of polyphenols from natural aronia juice on the immune system.\n\nTherefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as polyphenols and carotenoids in healthy and depressive subjects in order to use the known positive effects of these food sources in the therapeutic setting.\n\nThe consumption of natural fruit juices that are rich in polyphenols and carotenoids mirror a model of vegetarian diet due to the increased micronutrient density derived from plant food. Results obtained here can be seen as preliminary explanation models for the beneficial effects of vegetarian diet.\n\nIt is hypothesized, that the consumption of naturally polyphenol rich aronia juice changes the expression of regulatory T cells, specific cells of the immune system that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, the metabolome and the nutritional status are expected in the studied groups.\n\nThe study was registered retrospectively (after start of recruitment) on Clinicaltrials.gov.",[636,637,146,638,29],"Immune System Tolerance","Depression","Microbial Colonization",[640,641,642,643,644],"polyphenols","Aronia melanocarpa","immunomodulation","plant based food","natural food","2024-11-25",{"date":647,"type":37},"2024-11-27",{"date":649,"type":37},"2019-02-25",{"date":651,"type":22},"2026-01-31",{"name":653,"class":44},"Medical University of Graz",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":54,"minAge":167,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":23,"phases":663,"briefSummary":664,"conditions":665,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":78},"100559185","effectiveness-of-gut-microbiota-targeted-diatery-intervention-among-older-people-living-with-hiv-100559185","NCT06560840","Effectiveness of Gut Microbiota-targeted Diatery Intervention Among Older People Living With HIV","Effectiveness of Gut Microbiota-targeted Diatery Intervention in Preventing Atherosclerotic Cardiovascular Disease Among Older People Living With HIV","Inclusion Criteria:\n\n1. HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines;\n2. Aged 40 years and above;\n3. at risk of CVD: having any two of those risk factors: dyslipidemia, DM or elevated blood glucose, smoking, hypertention or elevated blood pressure, metabolic syndrome,overweight\u002Fobesity; or PCE score\\>5%,\n4. Those with a predicted survival time of \\>1 year;\n5. No plans to leave the depth in the next 3 months;\n6. Voluntary participation in this study and signing the informed consent\n\nExclusion Criteria:\n\n1. Those with a previous history of CVD;\n2. Those with HIV-related neurocognitive impairment, Alzheimer's disease or dementia, and a variety of serious opportunistic infections;\n3. Currently suffering from malignant tumors, gastrointestinal diseases; People with an aversion to eating;\n4. Allergic to nuts and fish;\n5. People who take medicinal calcium \\>1000 mg per day or omega-3 supplements;\n6. Plan to become pregnant within 6 months;\n7. Are participating in other HIV-related or dietary intervention-related scientific research programs.",{"count":662,"type":22},110,[25],"The goal of this clinical trial is to conduct a dietary intervention targeting HIV specific gut microbiota alterations for primary atherosclerotic cardiovascular disease (ASCVD) prevention and evaluate its effectiveness in preventing ASCVD among older people living with HIV (PLWH).",[666,667,29],"Hiv","Atherosclerosis","2024-09-24",{"date":670,"type":37},"2024-09-26",{"date":672,"type":37},"2024-08-20",{"date":674,"type":22},"2025-05-20",{"name":676,"class":44},"Fudan University",{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":681,"acronym":682,"eligibilityCriteria":683,"healthyVolunteers":16,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":684,"targetDuration":4,"studyType":271,"phases":4,"briefSummary":685,"conditions":686,"keywords":688,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":697,"completionDateStruct":699,"leadSponsor":701,"locationsCount":78},"100563113","dietcoach-development-and-dietitian-evaluation-of-a-digital-dietary-counseling-platform-100563113","NCT06611943","DietCoach: Development and Dietitian Evaluation of a Digital Dietary Counseling Platform","DietCoach","Inclusion Criteria:\n\n* Dietitians in Switzerland\n* German-speaking (the platform is in German, a main language in Switzerland)",{"count":215,"type":22},"The DietCoach study aims to investigate the requirements of a digital dietary counseling platform, and evaluate the dietitian acceptance and usability of the DietCoach platform, which was developed based on the collected requirements. Additionally, the study examines how different levels of patient food purchase data availability affect these factors. The DietCoach platform automatically tracks historic and up-to-date patient food purchase data on loyalty cards and provides nutritional analysis, assisting dietitians in the dietary counseling process. The key research questions (RQ) are:\n\n1. What are the requirements of a digital dietary counseling system based on food purchase data?\n2. What is acceptance and usability of the DietCoach platform evaluated by dietitians?\n3. How does the availability of patient food purchase data influence the acceptance and perceived usability of the DietCoach platform by dietitians?\n\nDietitians from several cantonal hospitals in the German-speaking area of Switzerland are invited to participate in the study. To answer RQ1, we conduct a workshop and a survey with dietitians to derive key requirements on dietary counseling systems. To answer RQ2 and RQ3, we use a cross-sectional, mixed-methods, between-subjects study design.\n\nResearchers will evaluate and compare the acceptance and usability of DietCoach in 3 different conditions (3 patients that had different, i.e., high, medium and low, food purchase data availability). Each participant is assigned to the data of one patient. Participants are required to:\n\n1. use the DietCoach platform to provide at least one dietary recommendation to patient food purchase data in two separate sessions.\n2. provide quantitative and qualitative feedback about the acceptance and usability of the DietCoach platform.",[687,462,460,29],"Dietary Habits",[689,690,691,692,693],"Digital dietary counseling","Food purchase data","Dietitian interface","eHealth","Human-Computer Interaction","2024-09-20",{"date":696,"type":37},"2024-09-25",{"date":698,"type":37},"2024-08-29",{"date":700,"type":22},"2024-12-30",{"name":702,"class":44},"University of St.Gallen"]