[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dietary-intervention\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dietary-intervention":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,50,87,112,141,172,199,224,272],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100569180","investigating-the-effects-of-beef-consumption-on-cognitive-and-brain-health-100569180",false,"NCT06690892","Investigating the Effects of Beef Consumption on Cognitive and Brain Health","Understanding the Cognitive and Brain Health Effects of Increasing Beef Consumption in Young Adults","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Males and females; Age 19-24\n* Willingness to adhere to the ready-to-eat beef intervention regimen\n* Lives within 75 miles of Lincoln, NE\n* BMI between 18.5 and 39.9\n* Not pregnant or nursing\n* No history of cognitive or metabolic diseases indicated by diagnosis, including neurodegenerative disease, stroke, Type 1 and 2 diabetes, metabolic syndrome, cardiovascular disease, liver disease, kidney disease, and cancer\n* No history of eating or anxiety disorders\n* Willing to discontinue dietary supplement use throughout the duration of the study, if they are consuming supplement at the time of the registration\n* No known contraindication to MRI scans as determined by the MRI screening survey questions\n\nExclusion Criteria:\n\n* Current use of medications that may affect their responses to dietary intervention, such as amphetamines, antidepressants, anti-diabetic medications, laxatives, antibiotics, statins and diuretics.\n* Known intolerance or allergy to beef\n* Current use of nicotine products, including vaping\n* Previous use of nicotine products, including vaping, within the recent 6 months at the time of pre-screening",true,"ALL","19 Years","24 Years",{"count":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn if eating more beef will lead to better cognition and a healthier brain in younger adults. The main questions it aims to answer are:\n\n* Does eating more beef lead to higher scores on cognitive tests and better quality of life?\n* Does eating more beef lead to better brain function?\n\nResearchers will compare participants in the experimental group (participants who will eat 25 ounces of beef every week during the dietary intervention) to control participants (participants who will eat 5 ounces of beef every week during the dietary intervention).\n\nParticipants will:\n\n* Be instructed to prepare and consume ready-to-eat beef meals along with their regular diet and not eat any more beef other than what they are given\n* Visit the study facilities once every week to pick up ready-to-eat beef meals; and complete a brief survey every week to track their consumption of the provided beef meals, and a dietary survey every 4 weeks\n* Visit the study facilities before and after the 12-week of intervention period for researchers to study them",[28,29,30,31],"Dietary Intervention","Dietary Proteins","Dietary Assessment","Cognitive Ability, General",[33,34,35,36],"beef consumption","beef dietary intervention","brain health","cognitive health","RECRUITING","2026-05-28",{"date":40,"type":41},"2026-05-29","ACTUAL",{"date":43,"type":41},"2025-09-22",{"date":45,"type":22},"2026-09",{"name":47,"class":48},"University of Nebraska Lincoln","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100629876","vegan-diet-and-immune-inflammatory-outcomes-in-asthma-and-healthy-adults-100629876","NCT07480369","Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults","The Effect of a Vegan Diet on Inflammatory and Immune Biomarkers in Adult Patients With Asthma and in Healthy Individuals: A Randomized Controlled Trial","VEGASTHMA","Inclusion Criteria:\n\nFor all groups:\n\n* Aged 18-30 years\n* Willing to adhere to assigned dietary plan (vegan or omnivorous) for 12 weeks\n* Non-smoker for at least 5 years\n* Body mass index (BMI) between 18.5 and 24.9 kg\u002Fm2\n\nFor the asthma group:\n\n* Clinical diagnosis of mild or moderate asthma (GINA criteria), made at least 12 months before enrollment\n* Stable asthma status (no exacerbations or changes in therapy within the past 3 months)\n* No change in pharmacotherapy during the study period\n\nExclusion Criteria:\n\n* Use of systemic corticosteroids (oral or intravenous) within the past 3 months\n* Ongoing biological therapy for asthma (e.g., anti-IgE, anti-IL-5, anti-IL-4R)\n* Severe asthma as per GINA criteria\n* Recent asthma exacerbation requiring hospitalization or steroid burst (\\\u003C3 months)\n* Presence of other chronic autoimmune or inflammatory diseases\n* Pregnancy or lactation\n* Active infection or acute illness at the time of recruitment\n* Adherence to specialized exclusion diets (e.g., ketogenic, low-FODMAP)\n* History of eating disorders\n* Inability or unwillingness to participate in follow-up visits or comply with the protocol","18 Years","50 Years",{"count":61,"type":22},280,[25],"This randomized controlled study evaluates the effects of a balanced vegan diet compared with a balanced omnivorous diet on inflammatory and immune response markers and clinical asthma parameters in healthy adults and individuals with mild to moderate asthma, aged 18 to 50. Participants will follow assigned dietary plans for 12 weeks with dietitian support delivered via digital tools.",[65,28,66],"Asthma","Vegan Diet",[68,69,70,71,72,73,74,75,76],"asthma","asthma control","inflammation","inflammatory markers","immune response","vegan diet","plant-based diet","randomized control trial","dietary intervention","NOT_YET_RECRUITING","2026-03-14",{"date":80,"type":41},"2026-03-18",{"date":82,"type":22},"2026-03",{"date":84,"type":22},"2029-09-30",{"name":86,"class":48},"Medical University of Gdansk",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":49},"100627351","effect-of-a-high-protein-high-fiber-pre-fast-meal-on-satiety-and-glycemic-profiles-during-fasting-100627351","NCT07447505","Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting","Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting: A Randomized Crossover Study","FAST-SAT","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Willingness to comply with study procedures, including fasting and continuous glucose monitoring\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Diagnosed diabetes mellitus or known metabolic disease\n* History of cardiovascular, gastrointestinal, or endocrine disorders that may affect study outcomes\n* Use of medications known to affect glucose metabolism or appetite\n* Pregnancy or lactation\n* Known allergy or intolerance to any study meal components (oats, dairy, peanuts, nuts, cranberries)",{"count":96,"type":22},38,[25],"This randomized crossover study investigates the effect of consuming a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours in healthy adults. Participants will complete two dietary conditions in a randomized order: a standardized high-protein, high-fiber pre-fast meal and a low-protein, low-fiber pre-fast meal guided by dietary instructions. Each condition will be followed for two consecutive days and separated by a three-day washout period. Outcomes include subjective appetite sensations during fasting hours, glycemic profiles assessed using continuous glucose monitoring (CGM), and exploratory analyses examining the association between glucose dynamics and appetite sensations.",[100,101,28,102],"Glycemic Response; Satiety","Fasting, Time Restricted","Postprandial Glucose","2026-03-10",{"date":105,"type":41},"2026-03-12",{"date":107,"type":41},"2026-02-23",{"date":109,"type":22},"2026-03-23",{"name":111,"class":48},"King Faisal University",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":120,"minAge":58,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100587492","effect-of-prenatal-and-postnatal-intervention-strategies-on-breastfeeding-outcomes-in-women-with-excessive-weight-ready-set-nourish-study-100587492","NCT06929091","Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)","Ready, Set, Nourish Study","RSN","Inclusion Criteria\n\n* Age 18 or older\n* Less than 37 weeks of pregnant with singleton fetus\n* Pre-pregnancy excessive weight (Body Mass Index ≥ 25 kg\u002Fm2)\n* Interested in breastfeeding\n* Willing to express colostrum from around 37 weeks of pregnancy if randomized to the prenatal intervention group\n* Willing to express human milk for sample collection during a 24-hour period\n* Willing to adhere to a meal plan for 5.5 months post-partum if randomized to the postnatal intervention group\n* Able to engage in study procedures for the first 24 months postpartum\n* Reside in Central Arkansas region Exclusion Criteria\n* Pre-existing conditions (e.g. diabetes, hypertension, heart disease, thyroid disorders);\n* Use of recreational drugs, tobacco, or 2 or more servings of alcohol per month\n* Food allergies, intolerances, or preferences interfering with the meal plan\n* Medical history including any contraindication to breastfeeding (medications or supplements incompatible with breastfeeding, substance use)Multiparous pregnancy\n* History of breast surgery or radiation\n* Congenital defects\n* Preeclampsia","FEMALE",{"count":21,"type":22},[25],"This study is about preparing women with excessive weight to have better breastfeeding outcomes. By doing this study, the investigators hope to learn more about how hand expression of breast milk or colostrum during pregnancy can help prepare a mother to breastfeed after she has her baby and about how her diet affects the composition of her breast milk and her baby's growth and development.",[125,28,126],"Breastfeeding","Milk Expression, Breast",[125,128,129,130],"Human Milk","Obesity","Health Diet","2025-12-04",{"date":133,"type":41},"2025-12-10",{"date":135,"type":41},"2025-11-07",{"date":137,"type":22},"2029-12-01",{"name":139,"class":48},"Arkansas Children's Hospital Research Institute",2,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":156,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":49},"100584635","groceries-for-residents-of-southeastern-usa-to-stop-hypertension-100584635","NCT06891911","Groceries for Residents of Southeastern USA to Stop Hypertension","GoFreshSE","Inclusion Criteria:\n\n1. Resting systolic blood pressure of 120 to \\\u003C160 mm Hg and diastolic blood pressure \\\u003C110 mm Hg\n2. Resident of Florida, Georgia, and Tennessee\n3. Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 4-week period\n4. Have access to refrigeration, cooking appliances, and Wi-Fi\u002Fcellular service\n5. Have access to mobile device or computer to be able to conduct grocery orders via video conference and send\u002Freceive text messages\n6. Willing and able to complete required measurement procedures\n7. Able to provide consent for the study\n8. Has access to a primary care team, urgent care center, or emergency room the study team can refer to for follow up care if warranted during the study\n\nExclusion Criteria:\n\nA. Laboratory Exclusions:\n\n1. Serum potassium ≥5.0 mmol\u002FL or \\\u003C3.5 mmol\u002FL\n2. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin per 1.73 m\\^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n3. Hemoglobin A1c ≥6.5%\n\nB. Medication Exclusions:\n\nUnstable doses (i.e. a change in the 6 months prior to screening or randomization or planning to start within study period) of the following:\n\n1. GLP-1 and dual GLP-1\u002FGIP receptor agonists\n2. Anti-hypertension medications\n3. Sodium-glucose co-transporter 2 (SGLT2) inhibitors\n4. Glucose lowering medications\n\nUse of any of the following medications:\n\n1. Potassium supplement, except if part of a multivitamin\n2. Warfarin (Coumadin)\n3. Chronic oral corticosteroid (intermittent use is okay)\n4. Weight loss medications (non-GLP-1 receptor agonists)\n5. Sulfonylurea or any insulin use\n\nAny medication not compatible with participation as determined by the investigators\n\nC. Physical Exclusions:\n\n1. Systolic blood pressure: \\\u003C120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg\n2. Arm circumference \\>52 cm (or the upper limit of the validated BP device)\n\nD. Medical History Exclusions:\n\n1. Self-reported weight loss or gain of 15 pounds during prior 2 months\n2. Active cardiovascular disease or any event in the prior 6 months, including coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) exacerbation requiring hospital admission\n3. Cancer diagnosis or treatment in the last 2 years (non-melanoma skin cancer or localized breast or prostate or bladder cancer not requiring systemic therapy is acceptable)\n4. Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence\n5. Pregnancy or lactation or planned pregnancy during the study period\n6. Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months\n7. Hypoglycemia hospitalization in the last 12 months\n8. Any other serious illness or condition not compatible with participation as determined by the investigators\n\nE. Lifestyle and Other Exclusions:\n\n1. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence\n2. Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week\n3. Active substance use disorder that would interfere with participation\n4. Extreme food insecurity\n5. Participation in or planning to start weight loss program\n6. Current participation in another clinical trial that could interfere with the study protocol\n7. Anticipated change in residence outside of eligible states prior to the end of the study\n8. Families with more than 6 adults at dinner time (children count as half an adult)\n\nF. Investigator discretion",{"count":149,"type":22},150,[25],"GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.",[153,154,155,28],"Hypertension","Elevated Blood Pressure","Cardiovascular Diseases",[153,157,158,159,160,161,162],"Dash Diet","Low Sodium","Diet","Nutrition","Clinical trial","Dietitian","2025-10-27",{"date":165,"type":41},"2025-10-28",{"date":167,"type":41},"2025-10-14",{"date":169,"type":22},"2026-06",{"name":171,"class":48},"Beth Israel Deaconess Medical Center",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":49},"100500802","eating-to-adjust-the-timing-system-100500802","NCT05800990","Eating to Adjust the Timing System","Do Dietary Patterns Influence Your Weight Management and Circadian Rhythms?","EATS","Inclusion Criteria:\n\n* 18-45 yr old\n* BMI 18.5-29.9\n* No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)\n* Without medication use (except oral contraceptives)\n\nExclusion Criteria:\n\n* Currently smoking\u002Fvaping or 5 or more years of smoking\u002Fvaping\n* History of drug or alcohol dependency\n* History of psychiatric illness or disorder\n* People with food allergies\u002Fintolerances or following specific diets","45 Years",{"count":182,"type":22},24,[25],"The goal of this clinical trial is to test the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure.\n\nParticipants will:\n\ncomplete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, and stool samples",[28],[187,188,189],"circadian rhythm","energy expenditure","appetite regulation","2025-09-25",{"date":192,"type":41},"2025-09-29",{"date":194,"type":41},"2024-11-08",{"date":196,"type":22},"2027-08-31",{"name":198,"class":48},"Brigham and Women's Hospital",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":49},"100582051","phase-3-patiromer-and-diethrqol-in-chronic-dialysis-100582051","NCT06858280","Patiromer and Diet\u002FhrQoL in Chronic Dialysis","Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial","PRINCE","Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):\n\n* More than 18-year-old\n* Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD\n* Pre-dialysis (in the long interdialytic period) serum potassium 4 to 5.5 mEq\u002FL confirmed in two consecutive weeks, without any clinical signs or symptoms of hyperkalemia\n* Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics\n* On standardized and stable (moderately or strictly restricted) low-potassium diet\n* Compliance with recommended diet\n* Written informed consent\n\nExclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial):\n\n* Hyperkalemia (pre-dialysis potassium \\>5.5 mEq\u002FL during the long interdialytic period)\n* Hypomagnesemia (serum magnesium \\\u003C1.7 mg\u002FdL)\n* Hypercalcemia (serum calcium \\>10.5mg\u002Fdl)\n* Ongoing treatment with potassium binding medications including Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or Sodium zirconium cyclosilate (Lokelma®, Astra Zeneca S.p.A.)\n* Ongoing treatment with potassium-sparing diuretics\n* Pre-dialysis potassium \\\u003C4.0 mEq\u002FL during the long interdialytic period\n* One or two weekly dialysis session\n* Poor compliance to prescribed potassium-restricted diet\n* History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders\n* Previous history of cardiac arrhythmias potentially related to hypokalemia\n* Known hypersensitivity to the active ingredient or any of the excipients of the study drug\n* Inability to fully understand the potential risks and benefits related to study participation\n* Concomitance of clinical conditions that could jeopardize the completion of the treatment period and\u002For confound data interpretation including:\n* Cancer (except non-metastatic cutaneous cancers)\n* Active systemic autoimmune diseases\n* Concomitant treatment with steroids or any other immunosuppressive agent\n* Severe\u002Funstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months\n* Refractory severe hypertension (BP \\>180\u002F100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications)\n* Known to be positive for human immunodeficiency virus\n* Drug or alcohol abuse\n* Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment\n* Intention to donate ova or sperm over the same period\n* Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2020\\_09\\_HMA\\_CTFG\\_Contraception\\_guidance\\_Version\\_1.1\\_updated.pdf)\n* Involvement in the study planning and\u002For conduct\n* Participation in another clinical study with an investigational product during the last month",{"count":208,"type":22},40,[210],"PHASE3","This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction without increasing the risk of hyperkalemia in chronic dialysis patients.",[213,214,28],"Hyperkalaemia","Chronic Kidney Disease Stage 3 and 4","2025-08-27",{"date":217,"type":41},"2025-09-04",{"date":219,"type":41},"2025-07-08",{"date":221,"type":22},"2026-07",{"name":223,"class":48},"Mario Negri Institute for Pharmacological Research",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":235,"conditions":236,"keywords":240,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100578274","phase-4-metabolic-and-behavioural-effects-of-contrave-as-potential-mechanisms-of-weight-loss-in-adults-with-obesity-100578274","NCT06809166","Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity","Identifying the Short-Term Neurobiological, Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial","Inclusion Criteria:\n\n1. Participants who are able to provide written informed consent prior to the initiation of any protocol-required procedures\n2. Have been referred to the LEAF clinic by their physician or have self-referred to the LEAF clinic for weight loss, and have been deemed appropriate for weight loss treatment offered by the LEAF clinic (i.e., these criteria are at the discretion of the clinical team at the LEAF clinic, outlined below in the exclusion criteria section).\n3. Adults: aged 18-64 years of age (gender and sex will be noted; recruitment is all-gender inclusive).\n4. Have a BMI\\>30.\n5. Have normal or corrected vision as some of the study aspects will involve viewing\u002Fresponding to visual stimuli.\n6. Understand and speak English (as instructions for study criteria will be provided in English).\n7. Able to participate in the study protocol as described, e.g. have a means of getting to the laboratories and no major mobility issues to the extent that protocols cannot be followed (details below).\n8. Access to a secure internet connection (for virtual appointments with members of the LEAF clinic).\n\nExclusion Criteria:\n\n1. Reporting severe depression or reporting significant suicidal ideation, or history of bipolar disorder or psychosis (i.e., major psychiatric condition; this will be ascertained during the screening carried out by research personnel, in keeping with our standard protocols in Dr. Jaworska's laboratory).\\*\\*\\*\n2. Current use of antidepressants, thyroid medication, or any medication that could affect appetite, or seizure threshold (e.g.., bupropion, tamoxifen, thioridazine).\n3. Uncontrolled hypertension.\n4. History of cardiac defects or symptoms suggestive of any cardiac condition (not including coronary artery disease).\n5. Presence of diabetes.\n6. Current or past history of addictions or substance use disorder, including undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.\n7. History of eating disorder (including Binge Eating Disorder, Bulimia Nervosa or Anorexia Nervosa).\n8. History of glaucoma.\n9. Personal or family history of seizure disorders.\n10. Currently taking MAO inhibitors (within 14 days), pressor agents, coumadin, anticonvulsants, or phenylbutazone, or other bupropion-containing products (such as Wellbutrin, Wellbutrin SR, Wellbutrin XL, Aplenzin or Zyban), or CYP2B6 inhibitors (e.g. ticlopidine or clopidogrel).\n11. History of thyroid disease, chronic liver, or renal disease.\n12. Chronic use of opioid, opiate agonist (Methadone) or partial agonists (Buprenorphine).\n13. Currently pregnant or planning to become pregnant during the intervention or currently nursing. Pregnancy urine test will be conducted during the in-person screening session in the laboratory.\\*\\*\\*\n14. No known allergy to any of the ingredients in CONTRAVE® (e.g. lactose).\n15. Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.\n16. Current use of obesity medications such as liraglutide or semaglutide or orlistat.\n17. Current use of medication indicated in patient living with ADHD (e.g., Vivanse\u002FConcerta) which are known to have metabolic impacts.\n\n    There are several additional exclusionary criteria, established by research personnel in Dr. Jaworska's laboratory (i.e., not part of LEAF intake) that preclude participation in the brain imaging\u002Fmagnetic resonance imaging (MRI) and EEG, these include:\n18. Severe claustrophobia.\n19. Inability to lie still in the scanner for approximately 30min.\n20. Metal in the body that cannot be removed and might pose a safety risk to the participant.\n21. History of concussion (loss of consciousness for \\>5-min).\n22. Major neurological illness, such as, epilepsy, stroke, tumours (as this would interfere with the interpretation of the MRI data).\n23. Obesity to the extent that the participant cannot fit into the scanner. This will be established by ensuring that the individual can fit into the mock scanner at the Brain Imaging Centre (BIC) of The Royal. If a person cannot fit into the mock scanner, it is unlikely that the person can fit into the real scanner.\n24. Testing positive for illicit drugs and cannabis (this will be established using a drug test that will be administered in the Clinical EEG \\& Neuroimaging laboratory at the Institute of Mental Health Research \\[IMHR\\]). Participants who are cannabis users will be invited to participate in the study so long as they can abstain from cannabis use for approximately 2weeks prior to the baseline session and approximately 2weeks before final assessment. Ideally, participants would also abstain from cannabis use during treatment, but, this will not be tested\u002Fenforced.\n25. Ability to abstain from nicotine\u002Ftobacco and caffeine for 3h prior to the baseline testing\u002FEEG recordings, as both substances influence EEG activity.\n\n    NOTE: If a participant cannot participate in the MRI aspect of the study (i.e., due to the above exclusion criteria), they will still be able to participate in the research study (apart from the MRI component). All MRI\u002FEEG exclusion criteria will be established during the screening\u002Fclinical interview carried out by trained research staff from Dr. Jaworska's laboratory (details below).\n\n    One final exclusion criterion is as follows:\n26. Unable to tolerate the test dose of CONTRAVE® (details below). Such individuals would not participate in further elements of the research, but, would continue with their treatment through the LEAF clinic (as determined by the LEAF clinic, per their clinical management program).","64 Years",{"count":208,"type":22},[234],"PHASE4","Obesity is a common chronic disease linked with increased risk for other illnesses and earlier death. Our team and others have shown that many bodily and psychological changes occur when individuals are on calorie-restricted diets. These changes might undermine dietary adherence and help to explain the relatively poor long-term efficacy of diets. These include increased appetite, increased food 'value' and 'wanting' that leads to overconsumption. Other factors include more sensitive sensory cues (e.g., smelling), higher food liking and craving, and a drop in resting energy expenditure (REE). REE has been shown to predict weight regain.\n\nThe standard care for obesity may include the use of the weight-loss drug CONTRAVE®. The Federal Drug Agency (FDA) and Health Canada have approved this drug for weight management and obesity treatment.\n\nAlthough CONTRAVE® was designed to reduce appetite, food-related impulsivity and cravings, its mechanisms of action are unclear. In other words, the effects of CONTRAVE® on REE, executive function, and brain changes remain unknown in humans. A better understanding of how this drug works on the brain and body could lead to improvements in obesity management in the future.\n\nAs such, the goal of this research is to study the effects of 4 weeks of CONTRAVE® (+ diet program) vs. control (placebo pill + diet program) on mood, body composition changes, biological\u002Fmetabolic measures, and brain measures.\n\nAdults aged 18-64 with obesity will be randomized to one of two groups: diet + CONTRAVE® (CONTRAVE®, 20 participants) or diet + Placebo (Placebo, 20 participants). Both groups will be assigned the same study procedures for the entire study duration. The only difference is that Group 1 will receive CONTRAVE® while Group 2 will receive a placebo (non-medical) pill.\n\nThe study design and intervention is as follows:\n\nParticipants who meet all the telephone screening criteria will be invited to the Clinical EEG \\& Neuroimaging Laboratory at The Royal's IMHR for an in-person screening and test-dose session. Participants who are cleared by the study physician, Dr. Pierre Blier, during the in-person screening will be enrolled in the 4-weeks trial.\n\nAfter the in-person screening visit, participants will attend two baseline testing visits (before starting the medication + diet program). The first will occur at the Behavioural and Metabolic Research Unit at the University of Ottawa. During this in-person visit, measures of body composition, resting energy expenditure, appetite, food craving, impulsivity, eating behaviours, taste and odour sensitivity, energy intake, and food preference will be collected.\n\nThe second baseline visit (within a week of the first one) will occur at The Royal\u002FIMHR. During this visit, participants will be asked to complete questionnaires. They will undergo an EEG recording while resting and performing computer tasks. They will also get a brain imaging scan, during which they are asked to rest and complete a computer task.\n\nBoth testing sessions (University of Ottawa and Royal Ottawa testing sessions) will be repeated after four weeks of treatment. The section below provides further description and timing of these visits.\n\nAs part of the treatment, you will receive an individualized dietary intervention with appropriate energy restriction from a registered dietitian at Dr. Judy Shiau's LEAF weight management clinic (called the 4-week BUDS program). The program involves weekly touch points with a registered dietitian and meal planning\u002Fcoaching. The diet intervention will commence the same week as the start of the placebo\u002FCONTRAVE®.\n\nDuring the 4-week intervention, participants will be asked to complete online questionnaires at various times.",[129,237,238,28,239],"Weight Loss","Weight Management","Obesity\u002FTherapy",[241,242,243,244,245,246,247,248,249,250,251,188,252,253,254,255,256,257,258,259,260,261],"contrave","EEG","MRI","weight loss","appetitive behaviour","executive functioning","mood and weight loss","mood","body composition","symptoms of anxiety","symptoms of depression","appetite","energy intake","food reward","reward processing","motivation","effort expenditure","delay discounting","brain activation","event related potentials","brain electrical activity","2025-07-21",{"date":264,"type":41},"2025-07-24",{"date":266,"type":41},"2024-07-04",{"date":268,"type":22},"2026-07-31",{"name":270,"class":48},"The Royal's Institute of Mental Health Research",3,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":292,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":49},"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":282,"type":22},300,[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.",[286,287,28,288,289,290,291],"Dietary Behaviour","Dietary Intakes","Metabolic Diseases","Blood Lipid Profiles","Blood Glucose Metabolism","Diet, Healthy",[293,294,295,296,297,298,299,300],"Cardiometabolic health","Lifestyle intervention","Dietary adherence","Sustainable diet","Nordic diet","Metabolic risk factors","Randomized controlled trial","nevironmental impact of diet","2025-05-14",{"date":303,"type":41},"2025-05-15",{"date":305,"type":41},"2025-03-03",{"date":307,"type":22},"2026-11-30",{"name":309,"class":48},"Chalmers University of Technology"]