Adolescent ObesityNCT06616454
The Effect of Time-Restricted Feeding on Body Composition and Some Metabolic Parameters in Obese Adolescents
A study testing Intervention group - Time restricted feeding in people with Adolescent Obesity, run by Sümeyra Başar at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Obesity
- What is being tested?
- Intervention group - Time restricted feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mustafa Eraslan and Fevzi Mercan Children's Hospital
Kayseri, 38039
Sümeyra Başar, +905386380089, sumeyra_akalin@hotmail.com
About this study
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.
- Conditions
- Adolescent Obesity
- Being tested
- Intervention group - Time restricted feeding
- Keywords
- Pediatric Obesity, Body Composition, Healthy Diet, Time-Restricted Eating
- Medical subject headings
- Pediatric Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group - Time restricted feedingBehavioural
Participants will be applied with an ad libitum nutrition plan between 10:00-18:00.
| Study group | Role | What they receive |
|---|---|---|
| Control group - Calorie-restricted feeding | Experimental | Participants will be applied a nutrition plan prepared in line with the principles of the Mediterranean Diet without any time restrictions. Receives: Behavioral: Intervention group - Time restricted feeding |
| Intervention group - Time restricted feeding | Experimental | Participants will be applied with an ad libitum nutrition plan between 10:00 and 18:00. Receives: Behavioral: Intervention group - Time restricted feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Changes in body weight will be examined as a result of the implemented nutrition plan.
Measured: Baseline, Week 4, Week 8 and Week 12
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.
Measured: Baseline, Week 4, Week 8 and Week 12
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.
Measured: Baseline, Week 4, Week 8 and Week 12
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.
Measured: Baseline and Week 12
Changes in glycated hemoglobin levels
As a result of the implemented nutrition plan, changes in glycated hemoglobin (HbA1c) levels will be evaluated.
Measured: Baseline and Week 12
Changes in insulin levels
As a result of the implemented nutrition plan, changes in insulin levels (measured in µIU/mL) will be evaluated.
Measured: Baseline and Week 12
Changes in hormone levels
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.
Measured: Baseline and Week 12
Changes in inflammatory markers
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start14 Oct 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a randomized controlled parallel design study in 60 adolescents with obesity (BMI% ≥ 95th percentile) aged 12-18 years (between puberty stage: 5) who were followed at Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital. Patients will be randomized to one of two treatment groups for a 12-week intervention. Group 1: Intervention group - Time-restricted feeding - Ad libitum feeding between 10:00-18:00 hours Group 2: Control group - Calorie-restricted feeding - Nutrition plan prepared in line with the principles of the Mediterranean Diet without time restrictions
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sümeyra Başar
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor-investigator, Sümeyra Başar, TC Erciyes University
- Investigators
- Sümeyra Başar, Study director, sumeyra_akalin@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616454
- Sponsor's protocol ID
- 2022/828
- Status last verified
- Feb 2025
- First submitted
- 11 Sep 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time-Restricted Feeding on Body Composition and Some Metabolic Parameters in Obese Adolescents
- ClinicalTrials.gov ID
- NCT06616454
- Acronym / sponsor ID
- 2022/828
- Conditions
- Adolescent Obesity
- Keywords
- Pediatric Obesity, Body Composition, Healthy Diet, Time-Restricted Eating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sümeyra BaşarUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was planned as a randomized controlled parallel design study in 60 adolescents with obesity (BMI% ≥ 95th percentile) aged 12-18 years (between puberty stage: 5) who were followed at Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital. Patients will be randomized to one of two treatment groups for a 12-week intervention. Group 1: Intervention group - Time-restricted feeding - Ad libitum feeding between 10:00-18:00 hours Group 2: Control group - Calorie-restricted feeding - Nutrition plan prepared in line with the principles of the Mediterranean Diet without time restrictions
| Arm | Type | Receives |
|---|---|---|
| Control group - Calorie-restricted feeding | Experimental | Behavioral: Intervention group - Time restricted feedingParticipants will be applied a nutrition plan prepared in line with the principles of the Mediterranean Diet without any time restrictions. |
| Intervention group - Time restricted feeding | Experimental | Behavioral: Intervention group - Time restricted feedingParticipants will be applied with an ad libitum nutrition plan between 10:00 and 18:00. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group - Time restricted feedingParticipants will be applied with an ad libitum nutrition plan between 10:00-18:00. | Behavioural | Control group - Calorie-restricted feeding, Intervention group - Time restricted feeding |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sümeyra Başar study director
sumeyra_akalin@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group - Time restricted feeding in people with Adolescent Obesity, run by Sümeyra Başar at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümeyra Başar (+ 90 538 638 0089, sumeyra_akalin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: Baseline, Week 4, Week 8 and Week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.