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

NCT ID: NCT07096505

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-21

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity and Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Early time restricted eating with calorie restriction

Intervention Type 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

Participants ate all meals between 12:00 and 20:00 daily with calorie restriction diet for 8 weeks.

Group Type EXPERIMENTAL

Delayed Time Restricted Eating with calorie restriction

Intervention Type 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

Participants ate all meals between 08:00 and 20:00 daily with calorie restriction diet for 8 weeks.

Group Type ACTIVE_COMPARATOR

Control group with calorie restriction

Intervention Type 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.

Interventions

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Early time restricted eating with calorie restriction

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.

Intervention Type BEHAVIORAL

Delayed Time Restricted Eating with calorie restriction

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.

Intervention Type BEHAVIORAL

Control group with calorie restriction

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SINEM BAYRAM

OTHER

Sponsor Role lead

Responsible Party

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SINEM BAYRAM

Assoc. Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sinem Bayram, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Locations

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Baskent University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KA23/107

Identifier Type: OTHER

Identifier Source: secondary_id

SINEM_TRE_2025

Identifier Type: -

Identifier Source: org_study_id

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