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Completed

NCT Number: NCT07096505

The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters

This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women.

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Key information

Conditions

Obesity and Metabolic Syndrome Behavior Body Weight Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Intermittent Fasting Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Smoking
  • Shift workers

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Change in Fasting Glucose (mg/dL)

    Time frame: From enrollment to the end of the treatment at 8 weeks

    Fasting blood glucose levels will be measured in mg/dL at baseline and after the 8-week intervention.

  2. Change in Fasting Insulin (μIU/mL)

    Time frame: From enrollment to the end of the treatment at 8 weeks

    Fasting serum insulin levels will be measured in μIU/mL at baseline and after the 8-week intervention.

  3. Change in HOMA-IR

    Time frame: From enrollment to the end of the treatment at 8 weeks

    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.

  4. Change in Total Cholesterol (mg/dL)

    Time frame: From enrollment to the end of the treatment at 8 weeks

    Serum Total Cholesterol will be measured in mg/dL at baseline and after the intervention.

  5. Change in Systolic and Diastolic Blood Pressure (mmHg)

    Time frame: From enrollment to the end of the treatment at 8 weeks

    Systolic and diastolic blood pressure will be measured using a standardized sphygmomanometer at baseline and after 8 weeks.

  6. Change in LDL Cholesterol (mg/dL)

    Time frame: From enrollment to the end of the treatment at 8 weeks

    Serum LDL cholesterol will be measured in mg/dL at baseline and after the intervention.

  7. Change in HDL Cholesterol (mg/dL)

    Time frame: From enrollment to the end of the treatment at 8 weeks

    Serum HDL cholesterol will be measured in mg/dL at baseline and after the intervention.

  8. Change in Triglycerides (mg/dL)

    Time frame: From enrollment to the end of the treatment at 8 weeks

    Serum triglyceride levels will be measured in mg/dL at baseline and after the intervention.

Sponsors and collaborators

Lead sponsor

SINEM BAYRAM

Other

Registry information

Official study title

The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters in Obese Women: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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