[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04949451":3,"trial-entities:NCT04949451":138,"trial-summary:NCT04949451":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":51,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":114,"locations":116,"central_contacts":132,"overall_officials":135,"references":136,"see_also_links":137},"NCT04949451","TRIMM062021","Time Restricted Feeding, Muscle, and Metabolism","Time Restricted Feeding Intervention for Muscle and Metabolic Health (TRIMM)","RECRUITING","2025-12-30","2025-08","2025-08-26","2021-06-13","University of Arkansas, Fayetteville","OTHER",false,"Effective nutrition strategies for combatting and\u002For preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting\u002Fpreventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and\u002For treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.",null,[19,20],"Overweight","Obesity",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},90,"ESTIMATED",[30,36,41],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIETARY_SUPPLEMENT","Whey protein supplement","Participants consume whey protein at the beginning of the eating period.",[35],"TRF-P",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Ketogenic aid","Participants consume ketogenic aid upon waking.",[40],"TRF-S",{"type":14,"name":42,"description":43,"armGroupLabels":44},"Control group - time restricted feeding only","Time restricted feeding.",[45],"TRF-C",[47],{"measure":48,"description":49,"timeFrame":50},"Body composition","Body composition measured using dual x-ray absorptiometry to determine the ration of lean\u002Ffat-free mass to fat mass.","Change is being assessed at baseline and final day (day 120) of the intervention.",[52,55,58,62,66,70,73,76,79,82,85,88],{"measure":53,"description":54,"timeFrame":50},"Whole body protein turnover","Whole body protein turnover will be measured using 15N-alanine",{"measure":56,"description":57,"timeFrame":50},"Muscle mass","Muscle mass will be measured using D3-creatine",{"measure":59,"description":60,"timeFrame":61},"Body weight","Body weight will be measured in kilograms.","Change is being assessed at baseline, 4, 8, and 12 weeks.",{"measure":63,"description":64,"timeFrame":65},"Sleep","Sleep will be assessed using wrist Actigraphy for sleep duration and total time in bed.","Change is being assessed at baseline and 12 weeks",{"measure":67,"description":68,"timeFrame":69},"Sleep Quality","Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey","Change is being assessed at baseline, 4, 8, and 12 weeks",{"measure":71,"description":72,"timeFrame":69},"Mood","Mood will be assessed using the Profile of Mood States Questionnaire",{"measure":74,"description":75,"timeFrame":69},"Grit","Grit will be assessed using the grit questionnaire.",{"measure":77,"description":78,"timeFrame":69},"Self-reported physical activity","Physical activity will be measured using the iPAQ survey",{"measure":80,"description":81,"timeFrame":69},"Dietary intake","Dietary intake will be measured using weighed, 3-day food records",{"measure":83,"description":84,"timeFrame":69},"Fasting glucose","Glucose will be measured as mg\u002Fdl",{"measure":86,"description":87,"timeFrame":69},"Hand grip","Hand grip will be measured using a dynamometer.",{"measure":89,"description":90,"timeFrame":69},"Amino acids and metabolites","Blood will be collected and plasma amino acids and metabolites will be assessed using commercially available kit for amino acid analysis for all circulating amino acids.","ALL","25 Years","50 Years",true,{"inclusion":96,"exclusion":102,"raw_text":113},[97,98,99,100,101],"Resides in Northwest Arkansas","Age 25-50 years","BMI \\> 25","All ethnicities","Female and male",[103,104,105,106,107,108,109,110,111,112],"Food allergies","Pregnant or breastfeeding","Dietary restrictions (e.g. vegetarian, vegan, etc.)","Trying to lose weight in last 3 months","Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension)","Prescription medications related to heart disease or type 2 diabetes","Fear of needles","Smoker or vaping","Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes","Consumes \\>4 alcoholic beverages per week","Inclusion Criteria:\n\n* Resides in Northwest Arkansas\n* Age 25-50 years\n* BMI \\> 25\n* All ethnicities\n* Female and male\n\nExclusion Criteria:\n\n* Food allergies\n* Pregnant or breastfeeding\n* Dietary restrictions (e.g. vegetarian, vegan, etc.)\n* Trying to lose weight in last 3 months\n* Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension)\n* Prescription medications related to heart disease or type 2 diabetes\n* Fear of needles\n* Smoker or vaping\n* Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes\n* Consumes \\>4 alcoholic beverages per week",[115],"ADULT",[117],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":129},"University of Arkansas","Fayetteville","Arkansas","72704","United States",[124],{"name":125,"role":126,"phone":127,"email":128},"Jamie I Baum, PhD","CONTACT","479-575-4474","baum@uark.edu",{"lat":130,"lon":131},36.06258,-94.15743,[133],{"name":134,"role":126,"phone":127,"email":128},"Jamie Baum, PhD",[],[],[],{"nct_id":4,"conditions":139,"biomarkers":140},[20,19],[],{"nct_id":4,"found":94,"summary":142,"prompt_version":152},{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This is an interventional study with a planned enrollment of 90 participants. It is not specified if it is randomized or blinded.","completed","Time Restricted Feeding, Muscle, and Metabolism Study","This study is looking at how time-restricted eating and protein supplements might help with overweight and obesity. Researchers want to understand how muscle mass affects appetite and energy intake. You might receive a whey protein supplement (a dietary supplement), a ketogenic aid (another dietary supplement), or be in a control group that only does time-restricted feeding. The main goal is to see how these interventions change your body composition (like how much fat and muscle you have) over 120 days. You can join if you are 25-50 years old, live in Northwest Arkansas, and have a BMI (Body Mass Index) over 25. The study is currently unclear on its recruitment status.","Body composition is assessed at baseline and on the final day (day 120) of the intervention.",111,"Body composition will be measured at the beginning and on the final day (day 120) of the intervention. Not specified in the trial record.","Not stated in the trial record.",[32,37],"v2"]