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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorSümeyra Başar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention group - Time restricted feeding

    Behavioral

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control group - Calorie-restricted feedingExperimental treatment 1 intervention
Group B: Intervention group - Time restricted feedingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in body weight

Changes in body weight will be examined as a result of the implemented nutrition plan.

Time frame
Baseline, Week 4, Week 8 and Week 12
2

Changes in body fat percentage

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.

Time frame
Baseline, Week 4, Week 8 and Week 12
3

Changes in body mass index

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.

Time frame
Baseline, Week 4, Week 8 and Week 12
4

Biochemical changes

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.

Time frame
Baseline and Week 12

Secondary outcomes

Other outcomes

Sponsors and contacts

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Sümeyra Başar

Lead sponsor

TC Erciyes University

Sponsor institution

Health Institutes of Turkey

Collaborator