Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 4:23 AM
Study NCT ID:
NCT07096505
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "A total of 36 obese women aged between 20-49 years were randomly assigned to one of three groups: Early Time-Restricted Eating (eTRE; 08:00-16:00), Delayed Time-Restricted Eating (dTRE; 12:00-20:00), and a Control group (08:00-20:00). A one-day physical activity log was used to assess the participants' physical activity levels. Total energy expenditure was calculated for all participants, and a 25% energy restriction was applied to design individualized medical nutrition therapy."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight (kg)', 'timeFrame': 'from enrollment to the end of treatment at 8 weeks', 'description': 'Body weight will be measured in kilograms using standardized procedures at baseline and at the end of the 8-week intervention.'}, {'measure': 'Change in Body Mass Index (BMI) (kg/m²)', 'timeFrame': 'from enrollment to the end of treatment at 8 weeks', 'description': 'Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), will be recorded at baseline and at the end of the 8-week intervention.'}, {'measure': 'Change in Waist Circumference (cm)', 'timeFrame': 'from enrollment to the end of treatment at 8 weeks', 'description': 'Waist circumference will be measured in centimeters at baseline and at the end of the 8-week intervention using standardized anthropometric procedures.'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Glucose (mg/dL)', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'Fasting blood glucose levels will be measured in mg/dL at baseline and after the 8-week intervention.'}, {'measure': 'Change in Fasting Insulin (μIU/mL)', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'Fasting serum insulin levels will be measured in μIU/mL at baseline and after the 8-week intervention.'}, {'measure': 'Change in HOMA-IR', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using fasting glucose and insulin values at baseline and after the 8-week intervention.'}, {'measure': 'Change in Total Cholesterol (mg/dL)', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'Serum Total Cholesterol will be measured in mg/dL at baseline and after the intervention.'}, {'measure': 'Change in Systolic and Diastolic Blood Pressure (mmHg)', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'Systolic and diastolic blood pressure will be measured using a standardized sphygmomanometer at baseline and after 8 weeks.'}, {'measure': 'Change in LDL Cholesterol (mg/dL)', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'Serum LDL cholesterol will be measured in mg/dL at baseline and after the intervention.'}, {'measure': 'Change in HDL Cholesterol (mg/dL)', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'Serum HDL cholesterol will be measured in mg/dL at baseline and after the intervention.'}, {'measure': 'Change in Triglycerides (mg/dL)', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'Serum triglyceride levels will be measured in mg/dL at baseline and after the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['time restricted eating', 'obesity', 'intermittent fasting', 'randomized controlled trial'], 'conditions': ['Obesity and Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women.', 'detailedDescription': "This randomized controlled trial investigates the effects of time-restricted eating with different timing windows on metabolic syndrome parameters. A total of 36 sedentary obese women aged between 20-49 years were randomly assigned to one of three groups: Early Time-Restricted Eating (eTRE; 08:00-16:00), Delayed Time-Restricted Eating (dTRE; 12:00-20:00), and a Control group (08:00-20:00). Participants' physical activity levels were assessed using a one-day physical activity log. Total energy expenditure was calculated, and a 25% energy restriction was applied to create individualized medical nutrition therapy. Anthropometric measurements, body composition, and biochemical parameters were collected before and after the 8-week intervention."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30 kg/m²\n* Able to follow dietary protocols\n* No chronic disease (T1DM, T2DM, cardiovascular disease, cancer)\n* Not on a weight loss diet in the past 6 months\n* No psychiatric disorder\n* Sedentary lifestyle\n\nExclusion Criteria:\n\n* Menopausal women\n* Cardiovascular disease\n* Type 1 or Type 2 Diabetes\n* Use of weight loss medications\n* Pregnant or breastfeeding\n* Smoking\n* Shift workers'}, 'identificationModule': {'nctId': 'NCT07096505', 'briefTitle': 'The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters in Obese Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SINEM_TRE_2025'}, 'secondaryIdInfos': [{'id': 'KA23/107', 'type': 'OTHER', 'domain': 'Başkent University Medical and Health Sciences Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Time-Restricted Eating with Calorie Restriction', 'description': 'Participants ate all meals between 08:00 and 16:00 daily with calorie restriction diet for 8 weeks.', 'interventionNames': ['Behavioral: Early time restricted eating with calorie restriction']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Time-Restricted Eating with Calorie Restriction', 'description': 'Participants ate all meals between 12:00 and 20:00 daily with calorie restriction diet for 8 weeks.', 'interventionNames': ['Behavioral: Delayed Time Restricted Eating with calorie restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'Participants ate all meals between 08:00 and 20:00 daily with calorie restriction diet for 8 weeks.', 'interventionNames': ['Behavioral: Control group with calorie restriction']}], 'interventions': [{'name': 'Early time restricted eating with calorie restriction', 'type': 'BEHAVIORAL', 'description': 'Participants followed a diet with 25% energy restriction and an 8-hour eating window from 08:00 to 16:00. Dietary compliance was monitored by dietitian through food consumption records.', 'armGroupLabels': ['Early Time-Restricted Eating with Calorie Restriction']}, {'name': 'Delayed Time Restricted Eating with calorie restriction', 'type': 'BEHAVIORAL', 'description': 'Participants followed a diet with 25% energy restriction and an 8-hour eating window from 12:00 to 20:00. Dietary compliance was monitored by dietitian through food consumption records.', 'armGroupLabels': ['Delayed Time-Restricted Eating with Calorie Restriction']}, {'name': 'Control group with calorie restriction', 'type': 'BEHAVIORAL', 'description': 'Participants followed a diet with 25% energy restriction and a usual eating window from 08:00 to 20:00. Dietary compliance was monitored by dietitian through food consumption records.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Sinem Bayram, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baskent University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interest in time-restricted eating and metabolic syndrome. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.', 'accessCriteria': 'Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SINEM BAYRAM', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'SINEM BAYRAM', 'investigatorAffiliation': 'Baskent University'}}}}