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NCT Number: NCT06616454

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

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.

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Key information

Conditions

Adolescent Obesity Behavior Body Weight Fasting Feeding Behavior Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mustafa Eraslan and Fevzi Mercan Children's Hospital

Kayseri, 38039, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sümeyra Başar

CONTACT

[email protected]

+905386380089

Who can participate

Healthy volunteers accepted: No

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

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.)

Treatment and study plan

Intervention group - Time restricted feeding

Behavioral

Participants will be applied with an ad libitum nutrition plan between 10:00-18:00.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sümeyra Başar

CONTACT

[email protected]

+ 90 538 638 0089

Zeynep Caferoğlu Akın

CONTACT

[email protected]

+90 537 766 3898

Sponsors and collaborators

Lead sponsor

Sümeyra Başar

Other

Collaborators

  • Health Institutes of Turkey

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
Feb 25, 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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