The Effect of Time-Restricted Feeding on Body Composition and Some Metabolic Parameters in Obese Adolescents

February 24, 2025 updated by: Sümeyra Başar
Obesity is now recognized as a serious public health problem. It is known that obesity seen in adolescence is largely carried over to adulthood. Therefore, its treatment is important both in terms of protecting current health and preventing diseases in adulthood. Reducing energy intake plays an important role in the treatment of obesity. However, long-term adherence and effectiveness to energy restriction appear to be limited. Therefore, the need for interventions that are "effective in body weight loss" and "accessible, simple and lifestyle modification to increase dietary compliance" is clear. Time-restricted feeding is a specialized intermittent fasting protocol that includes consistent fasting and eating periods over a 24-hour cycle by supporting circadian rhythms. Especially in the adult population, positive effects of time-restricted feeding such as weight loss and blood glucose regulation are observed. However, there are limited data on this subject for adolescents. Today, the Mediterranean diet, which is one of the nutrition models that supports health, is a beneficial nutritional model that reduces body weight and obesity-related comorbidities by limiting total energy intake. However, no study has been found in the literature in which the effectiveness of time-restricted nutrition, which is a new and promising approach, and the Mediterranean diet, which is a sustainable diet model, are evaluated together. Therefore, in this study, it was aimed to evaluate the effects of planned time-restricted nutrition compatible with circadian rhythm and energy-restricted feeding planned according to the Mediterranean diet model on body composition and various metabolic parameters in obese adolescents. 60 obese adolescents aged 12-18 years will be included in this randomized controlled and parallel design study. Participants will be randomized to one of two treatment groups for a 12-week intervention. The time-restricted feeding group will form the intervention group of the study, and the energy-restricted feeding group will form the control group. Anthropometric measurements of the participants at the beginning and end of the study will be taken, and various biochemical parameters will be evaluated with the body composition and blood samples to be taken. As a result of the study, it is expected to determine the effectiveness of time-restricted feeding compared to energy-restricted feeding in terms of dietary compliance, body composition and biochemical changes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Recruiting
        • Mustafa Eraslan and Fevzi Mercan Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adolescents aged 12-18 with puberty stage:5
  • Obese adolescents with a metabolic disorder (such as fatty liver, insulin resistance, prediabetes, dyslipidemia) (BMI≥95th percentile for age)
  • Those who have a stable body weight for 3 months before the start of the study (current weight gain or loss <4 kg)
  • Those who own and can use a Smartphone with Apple iOS or Android operating system
  • Those who speak, read and understand Turkish

Exclusion Criteria:

  • Those with any endocrine disorder, metabolic, chronic or major psychiatric disease other than obesity, insulin resistance, dyslipidemia, prediabetes, fatty liver
  • Polycystic ovary syndrome (PCOS)
  • Those with physical or mental disabilities
  • Those with allergies, intolerances or eating disorders
  • Those who smoke and drink alcohol
  • Use of drugs that may affect study results, circadian rhythms or metabolism (such as antidiabetics, steroids, beta blockers, adrenergic stimulating agents, laxatives, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group - Calorie-restricted feeding
Participants will be applied a nutrition plan prepared in line with the principles of the Mediterranean Diet without any time restrictions.
Behavioral: Intervention group - Time restricted feeding
Participants will be applied with an ad libitum nutrition plan between 10:00-18:00.
Experimental: Intervention group - Time restricted feeding
Participants will be applied with an ad libitum nutrition plan between 10:00 and 18:00.
Behavioral: Intervention group - Time restricted feeding
Participants will be applied with an ad libitum nutrition plan between 10:00-18:00.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body weight
Time Frame: Baseline, Week 4, Week 8 and Week 12
Changes in body weight will be examined as a result of the implemented nutrition plan.
Baseline, Week 4, Week 8 and Week 12
Changes in body fat percentage
Time Frame: Baseline, Week 4, Week 8 and Week 12
Changes in body fat percentage as a result of the implemented nutrition plan will be examined. The fat percentage will be assessed based on measurements taken with bioimpedance analysis devices.
Baseline, Week 4, Week 8 and Week 12
Changes in body mass index
Time Frame: Baseline, Week 4, Week 8 and Week 12
Changes in body mass index as a result of the implemented nutrition plan will be examined. Body mass index (BMI) will be calculated based on changes in height (cm) and weight (kg) values, using the formula kg/m².
Baseline, Week 4, Week 8 and Week 12
Biochemical changes
Time Frame: Baseline and Week 12
As a result of the implemented nutrition plan, changes in fasting glucose (mg/dL), total cholesterol (mg/dL), LDL cholesterol (LDL-C; mg/dL), HDL cholesterol (HDL-C; mg/dL), and triglycerides (mg/dL) levels will be evaluated.
Baseline and Week 12
Changes in glycated hemoglobin levels
Time Frame: Baseline and Week 12
As a result of the implemented nutrition plan, changes in glycated hemoglobin (HbA1c) levels will be evaluated.
Baseline and Week 12
Changes in insulin levels
Time Frame: Baseline and Week 12
As a result of the implemented nutrition plan, changes in insulin levels (measured in µIU/mL) will be evaluated.
Baseline and Week 12
Changes in hormone levels
Time Frame: Baseline and Week 12
At the conclusion of the implemented nutrition plan, changes in the levels of leptin, ghrelin, adiponectin, irisin, and nesfatin hormones (ng/mL) will be evaluated.
Baseline and Week 12
Changes in inflammatory markers
Time Frame: Baseline and Week 12
At the conclusion of the implemented nutrition plan, changes in various inflammation markers, including interleukin (IL)-17, IL-10, IL-6, IL-1β, and TNF-α (ng/mL), will be evaluated.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sümeyra Başar

Collaborators

Health Instuties of Türkiye

Investigators

  • Study Director: Sümeyra Başar, sumeyra_akalin@hotmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/828

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe