[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617133":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":44,"interventions":64,"overallOfficials":37,"centralContacts":78,"locations":87,"responsibleParty":105,"collaborators":37,"id":107,"slug":37,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":37,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":37,"enrollmentInfo":116,"targetDuration":37,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":37,"overallStatus":89,"whyStopped":37,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University of Surrey","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":37},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in body composition at 2 months using whole-body dual-energy x-ray absorptiometry (DEXA)","Measured using whole-body dual-energy x-ray absorptiometry (DEXA) In addition to the above, body composition will also be assessed using Tanita Bioelectrical impedance analysis (BIA). Fat free and fat mass will be reported in kg.","For 8 weeks of the assigned study intervention",{"measure":14,"description":15,"timeFrame":16},"Change from baseline in muscle function at 2 months","Measured using grip strength","At the start and end of 8 weeks of the assigned study intervention",{"measure":14,"description":18,"timeFrame":16},"Measured using 30-second sit-to-stand test.",[20,23,26,29,33],{"measure":21,"description":22,"timeFrame":16},"Change in fasting glucose control indicators","HbA1c",{"measure":24,"description":25,"timeFrame":16},"Change from baseline in insulin sensitivity at 2 months","HOMA-IR",{"measure":27,"description":28,"timeFrame":16},"Change from baseline in lipid metabolism at 2 months","fasting total, LDL- and HDL cholesterol and triglyerides",{"measure":30,"description":31,"timeFrame":32},"Change from baseline in diet composition at 2 months","Macro- and micronutrient analysis using the nutrition analysis platform Nutritics of 3-day food diaries administered at the start, mid-point and end of the assigned study intervention.","At the start, mid-point (week 4) and end of 8 weeks of the assigned study intervention",{"measure":34,"description":35,"timeFrame":36},"Feasibility of the assigned TRE intervention","semi-structured interviews","at the end of the 8 week intervention",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE",[45,51,56,61],{"label":46,"type":47,"description":48,"interventionNames":49},"TRE","EXPERIMENTAL","Participants undertaking the TRE intervention",[50],"Other: TRE",{"label":52,"type":47,"description":53,"interventionNames":54},"ProtAM TRE","Participants undertaking the ProtAM TRE intervention",[55],"Other: ProtAM TRE",{"label":57,"type":47,"description":58,"interventionNames":59},"ProtPM TRE","Participants undertaking the ProtPM TRE intervention",[60],"Other: ProtPM TRE",{"label":62,"type":63,"description":37,"interventionNames":37},"Control","NO_INTERVENTION",[65,68,73],{"type":6,"name":46,"description":66,"armGroupLabels":67,"otherNames":37},"* Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight.\n* Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea\u002Fcoffee, 0-calorie soft drinks.",[46],{"type":6,"name":52,"description":69,"armGroupLabels":70,"otherNames":71},"* Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight.\n* Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea\u002Fcoffee, 0-calorie soft drinks.\n* In addition, they will be asked to consume a protein drink containing 30g protein in the morning, 2 hours before the 8-hour eating window opens at 12pm (i.e. at 10am).",[52],[72],"TRE + morning protein 'snack'",{"type":6,"name":57,"description":74,"armGroupLabels":75,"otherNames":76},"* Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight.\n* Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea\u002Fcoffee, 0-calorie soft drinks.\n* In addition, they will be asked to consume a protein drink containing 30g protein in the afternoon, either 2 hours after their first meal or 2 hours before their last meal of the day.",[57],[77],"TRE + afternoon protein 'snack'",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":37,"email":83},"Yana Petkova","CONTACT","+44 7513 679 635","yp00228@surrey.ac.uk",{"name":85,"role":81,"phone":37,"phoneExt":37,"email":86},"Dr Collins","a.collins@surrey.ac.uk",[88],{"facility":5,"status":89,"city":90,"state":37,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"RECRUITING","Guildford","GU2 7XH","United Kingdom","UK",{"type":95,"coordinates":96},"Point",[97,98],-0.57427,51.23536,{"lat":98,"lon":97},[101,102,103],{"name":80,"role":81,"phone":82,"phoneExt":37,"email":83},{"name":85,"role":81,"phone":37,"phoneExt":37,"email":86},{"name":85,"role":104,"phone":37,"phoneExt":37,"email":37},"PRINCIPAL_INVESTIGATOR",{"type":106,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100617133",false,"NCT07314658","Time-restricted Eating (TRE) and Protein in Older Adults","The Effects of Time-restricted Eating (TRE) With and Without Additional Protein on Body Composition, Muscle Function and Markers of Metabolic Health in Older Adults","Inclusion Criteria:\n\n* Gender: male and female\n* Age range: 60 years or older\n* Fasting for 12 or less hours on a daily basis\n* BMI range: 23-30 kg\u002Fm2\n* Weight stability: no more than 3kg weight gain or loss in the past 3 months\n* Regular eating pattern, i.e. 3 meals a day\n* Able to prepare the protein supplement\n\nExclusion Criteria:\n\n* Any of the following present (in line with exclusion criteria used in previous TRE research in older adults):\n\n  * known renal impairment\n  * heart attack or stroke in the past three months\n  * continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure\n  * rheumatoid arthritis\n  * Parkinson's disease\n  * active treatment for cancer in the past year\n  * insulin dependent diabetes mellitus\n* taking medications that preclude fasting for 16 h\n* actively trying or planning to lose weight\n* history of an eating disorder\n* outside of stated age or BMI range\n* fasting for longer than 12 hours on a daily basis\n* unable to prepare the protein supplement\n* extreme morning\u002Fevening chronotype\n* sleep disorders\n* regular meal skipping\n* history of difficulty having a blood sample taken\n* Recent exposure to high-dose radiation\n* Vigorous exercise on more than 3 occasions a week",true,"ALL","60 Years",{"count":117,"type":118},80,"ESTIMATED","INTERVENTIONAL",[121],"NA","The aim this study is to investigate the effects of time-restricted eating (TRE) on body composition, muscle function and markers of metabolic health of adults over 60 years old. This study will compare different variations of TRE - with and without an additional protein.\n\nThis study involves attending two study days at the University of Surrey for baseline and end-of-intervention measurement of body composition using a gold-standard dual energy x-ray absorptiometry (DEXA) scan; muscle function using hand grip strength and 30-second sit-to-stand tests; weight. A blood sample will be taken at each study visit to measure markers of lipid and glucose control, and insulin sensitivity.\n\nParticipants will be randomly allocated to one of four study groups:\n\n* control group: maintain habitual dietary patterns\n* TRE group: fast for 16 hours overnight, eat between 12-8pm\n* TRE + Protein (AM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the morning\n* TRE + Protein (PM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the afternoon Participants will be asked to follow the intervention according to their allocated group for 8 weeks.",[124],"Generally Healthy Adults Over 60 Years Old","2025-12-17",{"date":127,"type":128},"2026-01-02","ACTUAL",{"date":130,"type":118},"2025-12",{"date":132,"type":118},"2027-07",{"name":5,"class":6},1]