NCT06616454Recruiting
The Effect of Time-Restricted Feeding on Body Composition and Some Metabolic Parameters in Obese Adolescents
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 11 Sept 2024
- Start date
- 14 Oct 2024
- Primary completion date
- 15 May 2025
- Lead sponsor
- Sümeyra Başar
- Diseases
- Obesity
- NCT number
- NCT06616454
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 14 Oct 2024 to the primary completion date, 15 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of drugs that may affect study results, circadian rhythms or metabolism (such as antidiabetics, steroids, beta blockers, adrenergic stimulating agents, laxatives, etc.)
Other illness
- 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 allergies, intolerances or eating disorders
Other
- Those with physical or mental disabilities
- Those who smoke and drink alcohol
Who the study is looking for
- 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
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mustafa Eraslan and Fevzi Mercan Children's Hospital Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.