Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 9:26 AM
Study NCT ID:
NCT07314658
Status:
RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time-restricted Eating (TRE) and Protein in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014198', 'term': 'Trehalase'}], 'ancestors': [{'id': 'D004186', 'term': 'Disaccharidases'}, {'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-30', 'size': 412447, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-17T07:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in body composition at 2 months using whole-body dual-energy x-ray absorptiometry (DEXA)', 'timeFrame': 'For 8 weeks of the assigned study intervention', 'description': '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.'}, {'measure': 'Change from baseline in muscle function at 2 months', 'timeFrame': 'At the start and end of 8 weeks of the assigned study intervention', 'description': 'Measured using grip strength'}, {'measure': 'Change from baseline in muscle function at 2 months', 'timeFrame': 'At the start and end of 8 weeks of the assigned study intervention', 'description': 'Measured using 30-second sit-to-stand test.'}], 'secondaryOutcomes': [{'measure': 'Change in fasting glucose control indicators', 'timeFrame': 'At the start and end of 8 weeks of the assigned study intervention', 'description': 'HbA1c'}, {'measure': 'Change from baseline in insulin sensitivity at 2 months', 'timeFrame': 'At the start and end of 8 weeks of the assigned study intervention', 'description': 'HOMA-IR'}, {'measure': 'Change from baseline in lipid metabolism at 2 months', 'timeFrame': 'At the start and end of 8 weeks of the assigned study intervention', 'description': 'fasting total, LDL- and HDL cholesterol and triglyerides'}, {'measure': 'Change from baseline in diet composition at 2 months', 'timeFrame': 'At the start, mid-point (week 4) and end of 8 weeks of the assigned study intervention', 'description': '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.'}, {'measure': 'Feasibility of the assigned TRE intervention', 'timeFrame': 'at the end of the 8 week intervention', 'description': 'semi-structured interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generally Healthy Adults Over 60 Years Old']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "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/m2\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/evening 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"}, 'identificationModule': {'nctId': 'NCT07314658', 'briefTitle': 'Time-restricted Eating (TRE) and Protein in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '361019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRE', 'description': 'Participants undertaking the TRE intervention', 'interventionNames': ['Other: TRE']}, {'type': 'EXPERIMENTAL', 'label': 'ProtAM TRE', 'description': 'Participants undertaking the ProtAM TRE intervention', 'interventionNames': ['Other: ProtAM TRE']}, {'type': 'EXPERIMENTAL', 'label': 'ProtPM TRE', 'description': 'Participants undertaking the ProtPM TRE intervention', 'interventionNames': ['Other: ProtPM TRE']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'TRE', 'type': 'OTHER', 'description': '* 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/coffee, 0-calorie soft drinks.', 'armGroupLabels': ['TRE']}, {'name': 'ProtAM TRE', 'type': 'OTHER', 'otherNames': ["TRE + morning protein 'snack'"], 'description': '* 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/coffee, 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).', 'armGroupLabels': ['ProtAM TRE']}, {'name': 'ProtPM TRE', 'type': 'OTHER', 'otherNames': ["TRE + afternoon protein 'snack'"], 'description': '* 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/coffee, 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.', 'armGroupLabels': ['ProtPM TRE']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7XH', 'city': 'Guildford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Yana Petkova', 'role': 'CONTACT', 'email': 'yp00228@surrey.ac.uk', 'phone': '+44 7513 679 635'}, {'name': 'Dr Collins', 'role': 'CONTACT', 'email': 'a.collins@surrey.ac.uk'}, {'name': 'Dr Collins', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Surrey', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'centralContacts': [{'name': 'Yana Petkova', 'role': 'CONTACT', 'email': 'yp00228@surrey.ac.uk', 'phone': '+44 7513 679 635'}, {'name': 'Dr Collins', 'role': 'CONTACT', 'email': 'a.collins@surrey.ac.uk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not required or applicable for this study protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}