Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT07189234
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014198', 'term': 'Trehalase'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D004186', 'term': 'Disaccharidases'}, {'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glucose Levels', 'timeFrame': '54 weeks', 'description': 'Assessed via HbA1c (%)'}], 'secondaryOutcomes': [{'measure': 'Change in glycemic variability', 'timeFrame': '54 weeks', 'description': 'Measured by continuous glucose monitor (CGM)'}, {'measure': 'Change in direct LDL-C', 'timeFrame': '54 weeks', 'description': 'LDL cholesterol (mg/dl)'}, {'measure': 'Change in bone density', 'timeFrame': '54 weeks', 'description': 'Bone density measured by DEXA scan (g/cm\\^2)'}, {'measure': 'Change in insulin sensitivity', 'timeFrame': '54 weeks', 'description': 'Measured by oral glucose tolerance test (OGTT)'}, {'measure': 'Changes in muscle mass', 'timeFrame': '54 weeks', 'description': 'Muscle mass measured by DEXA scan (kg)'}, {'measure': 'Change in body fat', 'timeFrame': '54 weeks', 'description': 'Measured by body fat percentage via DEXA scan (%)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Time Restricted Eating', 'Fasting'], 'conditions': ['Metabolic Syndrome', 'Pre-diabetes']}, 'referencesModule': {'references': [{'pmid': '35732151', 'type': 'BACKGROUND', 'citation': 'Taub PR, Panda S. Time for better time-restricted eating trials to lessen the burden of metabolic diseases. Cell Rep Med. 2022 Jun 21;3(6):100665. doi: 10.1016/j.xcrm.2022.100665.'}]}, 'descriptionModule': {'briefSummary': 'In a randomized controlled trial, the investigators intend to measure the health impact of time restricted eating (TRE) in patients with metabolic syndrome (with elevated blood pressure and at least 2 of the following: increased waist circumference, abnormal cholesterol levels, elevated triglycerides, and elevated fasting glucose levels), who habitually eat more than 12 hours every day. Patients will be randomly assigned to a control group (standard of care) or intervention group (TRE).', 'detailedDescription': 'Circadian rhythms optimize nutrient homeostasis by orchestrating catabolic and anabolic metabolism to appropriate times of the 24 hour day. Chronic circadian rhythm disruption predisposes individuals to metabolic diseases including obesity and type 2 diabetes. Conversely, maintaining a daily rhythm of feeding and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and results in improved metabolism. Time-restricted eating (TRE) is a specific feeding-fasting pattern in which feeding is restricted to 8-12 hours a day.\n\nOver the 54-week duration of the study, participants will be required to use a smartphone application (myCircadianClock, developed by the Salk Institute) to log all food and beverage intake. Investigators will measure height, weight, waist circumference, and blood pressure throughout the study. Blood tests will be done after an overnight fast to check HbA1C, glucose, insulin, lipids, and an NMR lipoprotein profile. Blood sugar will also be monitored continuously using a continuous glucose monitor (CGM) worn for 2 weeks at the beginning of the study, at 6 months, and at 12 months (end of the study). At these same three timepoints, participants will also wear a wrist-worn actigraphy device (actiwatch) to track physical activity and sleep patterns. Body composition will be measured using a dual energy X-ray absorptiometry (DEXA) scan, and an oral glucose tolerance test (OGTT) will be performed to assess how the body responds to sugar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age: 18-75 years\n2. HbA1c: 5.7% to 7.0%\n3. Metabolic syndrome (must meet 3 criteria): Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg (required) and 2 of the following:\n\n * Elevated waist circumference:\n\n * In Asians: ≥ 90 cm in men, ≥80 cm in women\n * In all other races: ≥ 102 cm in men, ≥ 88 cm in women\n * Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides\n * Reduced High-density lipoprotein (HDL)- cholesterol \\< 40 mg/dL in males or \\< 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol\n * Fasting glucose ≥ 100 mg/dL\n4. Own a smartphone (Apple iOS or Android OS)\n5. Baseline eating period ≥12 hour/day\n6. Patients on a stable dose of cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, other lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive drugs, GLP-1R agonists and SGLT2 inhibitors) for at least 3 months are allowed.\n\nExclusion Criteria:\n\n1. Use of sulfonylurea or insulin.\n2. HbA1C \\> 7.0%\n3. Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan.\n4. Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions.\n5. Shift workers with variable (e.g. nocturnal) hours.\n6. Frequent travel to different time zones during the study period.\n7. Active tobacco use or illicit drug use or history of treatment for alcohol abuse.\n8. History of major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack).\n9. Uncontrolled arrhythmia (i.e. rate -controlled atrial fibrillation / atrial flutter are not exclusion criteria)\n10. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).\n11. History of adrenal disease.\n12. History of malignancy undergoing active treatment, except non-melanoma skin cancer.\n13. Known history of type 1 diabetes.\n14. History of an eating disorder.\n15. History of cirrhosis.\n16. History of stage 4 or 5 chronic kidney disease or requiring dialysis.\n17. Currently enrolled in a weight-loss or weight-management program.\n18. On a special or prescribed diet for other reasons (e.g. Celiac disease).\n19. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).'}, 'identificationModule': {'nctId': 'NCT07189234', 'acronym': 'TIMET 2', 'briefTitle': 'Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'TIMET 2.0 - Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health', 'orgStudyIdInfo': {'id': '812281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time-restricted eating (TRE)', 'description': 'Participants in this arm will be asked to maintain their current lifestyle and medication management routines, while adhering to a daily, consistent 10-hour eating window. They will also receive standard lifestyle coaching, including meetings with a dietician to review dietary intake, and are required to track their caloric intake using a smartphone app.', 'interventionNames': ['Behavioral: Time-restricted eating (TRE) + Standard of Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of care (SOC)', 'description': 'Participants in this arm will maintain their current lifestyle and medication management without adhering to the 10-hour eating window. They will receive standard lifestyle coaching, including meetings with a dietician to review dietary intake, and will be asked to track their caloric intake using a smartphone app.', 'interventionNames': ['Behavioral: Standard of Care']}], 'interventions': [{'name': 'Time-restricted eating (TRE) + Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will adhere to a daily, consistent 10-hour eating window for the course of the study as well as receive nutritional counseling from the study dietician.', 'armGroupLabels': ['Time-restricted eating (TRE)']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt the 10-hour eating window.', 'armGroupLabels': ['Standard of care (SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gavin McLaren', 'role': 'CONTACT', 'email': 'preventivecvresearch@health.ucsd.edu', 'phone': '(858) 246-2342'}, {'name': 'Pam Taub, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Altman Clinical and Translational Research Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Gavin McLaren', 'role': 'CONTACT', 'email': 'preventivecvresearch@health.ucsd.edu', 'phone': '(858) 246-2342'}], 'overallOfficials': [{'name': 'Pam Taub, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC San Diego Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Salk Institute for Biological Studies', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Pam Taub, MD', 'investigatorAffiliation': 'University of California, San Diego'}}}}