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| ID | Type | Description | Link |
|---|---|---|---|
| KA23/107 | Other Identifier | Başkent University Medical and Health Sciences Research Ethics Committee |
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This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Time-Restricted Eating with Calorie Restriction | Experimental | Participants ate all meals between 08:00 and 16:00 daily with calorie restriction diet for 8 weeks. |
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| Delayed Time-Restricted Eating with Calorie Restriction | Experimental | Participants ate all meals between 12:00 and 20:00 daily with calorie restriction diet for 8 weeks. |
|
| control | Active Comparator | Participants ate all meals between 08:00 and 20:00 daily with calorie restriction diet for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early time restricted eating with calorie restriction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight (kg) | Body weight will be measured in kilograms using standardized procedures at baseline and at the end of the 8-week intervention. | from enrollment to the end of treatment at 8 weeks |
| Change in Body Mass Index (BMI) (kg/m²) | 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. | from enrollment to the end of treatment at 8 weeks |
| Change in Waist Circumference (cm) | Waist circumference will be measured in centimeters at baseline and at the end of the 8-week intervention using standardized anthropometric procedures. | from enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Glucose (mg/dL) | Fasting blood glucose levels will be measured in mg/dL at baseline and after the 8-week intervention. | From enrollment to the end of the treatment at 8 weeks |
| Change in Fasting Insulin (μIU/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sinem Bayram, Assoc. Prof. | Baskent University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baskent University | Ankara | Turkey (Türkiye) |
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.
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.
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).
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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.
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| Delayed Time Restricted Eating with calorie restriction | Behavioral | 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. |
|
| Control group with calorie restriction | Behavioral | 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. |
|
Fasting serum insulin levels will be measured in μIU/mL at baseline and after the 8-week intervention.
| From enrollment to the end of the treatment at 8 weeks |
| Change in HOMA-IR | 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. | From enrollment to the end of the treatment at 8 weeks |
| Change in Total Cholesterol (mg/dL) | Serum Total Cholesterol will be measured in mg/dL at baseline and after the intervention. | From enrollment to the end of the treatment at 8 weeks |
| Change in Systolic and Diastolic Blood Pressure (mmHg) | Systolic and diastolic blood pressure will be measured using a standardized sphygmomanometer at baseline and after 8 weeks. | From enrollment to the end of the treatment at 8 weeks |
| Change in LDL Cholesterol (mg/dL) | Serum LDL cholesterol will be measured in mg/dL at baseline and after the intervention. | From enrollment to the end of the treatment at 8 weeks |
| Change in HDL Cholesterol (mg/dL) | Serum HDL cholesterol will be measured in mg/dL at baseline and after the intervention. | From enrollment to the end of the treatment at 8 weeks |
| Change in Triglycerides (mg/dL) | Serum triglyceride levels will be measured in mg/dL at baseline and after the intervention. | From enrollment to the end of the treatment at 8 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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