The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters in Obese Women: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in Body Weight (kg)
Study Overview
Brief Summary
This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI > 30 kg/m²
- •Able to follow dietary protocols
- •No chronic disease (T1DM, T2DM, cardiovascular disease, cancer)
- •Not on a weight loss diet in the past 6 months
- •No psychiatric disorder
- •Sedentary lifestyle
Exclusion Criteria
- •Menopausal women
- •Cardiovascular disease
- •Type 1 or Type 2 Diabetes
- •Use of weight loss medications
- •Pregnant or breastfeeding
- •Shift workers
Arms & Interventions
Early Time-Restricted Eating with Calorie Restriction
Participants ate all meals between 08:00 and 16:00 daily with calorie restriction diet for 8 weeks.
Intervention: Early time restricted eating with calorie restriction (Behavioral)
Delayed Time-Restricted Eating with Calorie Restriction
Participants ate all meals between 12:00 and 20:00 daily with calorie restriction diet for 8 weeks.
Intervention: Delayed Time Restricted Eating with calorie restriction (Behavioral)
control
Participants ate all meals between 08:00 and 20:00 daily with calorie restriction diet for 8 weeks.
Intervention: Control group with calorie restriction (Behavioral)
Outcomes
Primary Outcomes
Change in Body Weight (kg)
Time Frame: from enrollment to the end of treatment at 8 weeks
Body weight will be measured in kilograms using standardized procedures at baseline and at the end of the 8-week intervention.
Change in Body Mass Index (BMI) (kg/m²)
Time Frame: from enrollment to the end of treatment at 8 weeks
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.
Change in Waist Circumference (cm)
Time Frame: from enrollment to the end of treatment at 8 weeks
Waist circumference will be measured in centimeters at baseline and at the end of the 8-week intervention using standardized anthropometric procedures.
Change in Body Weight (kg)
Time Frame: from enrollment to the end of treatment at 8 weeks
Body weight will be measured in kilograms using standardized procedures at baseline and at the end of the 8-week intervention.
Change in Body Mass Index (BMI) (kg/m²)
Time Frame: from enrollment to the end of treatment at 8 weeks
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.
Change in Waist Circumference (cm)
Time Frame: from enrollment to the end of treatment at 8 weeks
Waist circumference will be measured in centimeters at baseline and at the end of the 8-week intervention using standardized anthropometric procedures.
Secondary Outcomes
- Change in HOMA-IR(From enrollment to the end of the treatment at 8 weeks)
- Change in Fasting Glucose (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in Fasting Insulin (μIU/mL)(From enrollment to the end of the treatment at 8 weeks)
- Change in HOMA-IR(From enrollment to the end of the treatment at 8 weeks)
- Change in Total Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in Systolic and Diastolic Blood Pressure (mmHg)(From enrollment to the end of the treatment at 8 weeks)
- Change in LDL Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in HDL Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in Triglycerides (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in Fasting Glucose (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in Fasting Insulin (μIU/mL)(From enrollment to the end of the treatment at 8 weeks)
- Change in Total Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in Systolic and Diastolic Blood Pressure (mmHg)(From enrollment to the end of the treatment at 8 weeks)
- Change in LDL Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in HDL Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
- Change in Triglycerides (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
Investigators
SINEM BAYRAM
Assoc. Prof.
Baskent University