Obesity and Metabolic SyndromeNCT07096505
The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters
A study testing Early time restricted eating with calorie restriction and Delayed Time Restricted Eating with calorie restriction in people with Obesity and Metabolic Syndrome, run by SINEM BAYRAM at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Metabolic Syndrome
- What is being tested?
- Early time restricted eating with calorie restriction and Delayed Time Restricted Eating with calorie restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jul 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 30 kg/m²
- Able to follow dietary protocols
- No chronic disease (T1DM, T2DM, cardiovascular disease, cancer)
- Not on a weight loss diet in the past 6 months
- No psychiatric disorder
- Sedentary lifestyle
Who cannot join
- Menopausal women
- Cardiovascular disease
- Type 1 or Type 2 Diabetes
- Use of weight loss medications
- Pregnant or breastfeeding
- Smoking
- Shift workers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters in Obese Women: A Randomized Controlled Trial
This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women.
Read the detailed description
This randomized controlled trial investigates the effects of time-restricted eating with different timing windows on metabolic syndrome parameters. A total of 36 sedentary obese women aged between 20-49 years were randomly assigned to one of three groups: Early Time-Restricted Eating (eTRE; 08:00-16:00), Delayed Time-Restricted Eating (dTRE; 12:00-20:00), and a Control group (08:00-20:00). Participants' physical activity levels were assessed using a one-day physical activity log. Total energy expenditure was calculated, and a 25% energy restriction was applied to create individualized medical nutrition therapy. Anthropometric measurements, body composition, and biochemical parameters were collected before and after the 8-week intervention.
- Conditions
- Obesity and Metabolic Syndrome
- Being tested
- Early time restricted eating with calorie restriction, Delayed Time Restricted Eating with calorie restriction, Control group with calorie restriction
- Keywords
- time restricted eating, obesity, intermittent fasting, randomized controlled trial
- Medical subject headings
- Obesity, Metabolic Syndrome, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early time restricted eating with calorie restrictionBehavioural
Participants followed a diet with 25% energy restriction and an 8-hour eating window from 08:00 to 16:00. Dietary compliance was monitored by dietitian through food consumption records.
Delayed Time Restricted Eating with calorie restrictionBehavioural
Participants followed a diet with 25% energy restriction and an 8-hour eating window from 12:00 to 20:00. Dietary compliance was monitored by dietitian through food consumption records.
Control group with calorie restrictionBehavioural
Participants followed a diet with 25% energy restriction and a usual eating window from 08:00 to 20:00. Dietary compliance was monitored by dietitian through food consumption records.
| Study group | Role | What they receive |
|---|---|---|
| Early Time-Restricted Eating with Calorie Restriction | Experimental | Participants ate all meals between 08:00 and 16:00 daily with calorie restriction diet for 8 weeks. Receives: Behavioral: Early time restricted eating with calorie restriction |
| Delayed Time-Restricted Eating with Calorie Restriction | Experimental | Participants ate all meals between 12:00 and 20:00 daily with calorie restriction diet for 8 weeks. Receives: Behavioral: Delayed Time Restricted Eating with calorie restriction |
| control | Active comparator | Participants ate all meals between 08:00 and 20:00 daily with calorie restriction diet for 8 weeks. Receives: Behavioral: Control group with calorie restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight (kg)
Body weight will be measured in kilograms using standardized procedures at baseline and at the end of the 8-week intervention.
Measured: from enrollment to the end of treatment at 8 weeks
Change in Body Mass Index (BMI) (kg/m²)
Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), will be recorded at baseline and at the end of the 8-week intervention.
Measured: from enrollment to the end of treatment at 8 weeks
Change in Waist Circumference (cm)
Waist circumference will be measured in centimeters at baseline and at the end of the 8-week intervention using standardized anthropometric procedures.
Measured: from enrollment to the end of treatment at 8 weeks
Secondary outcomes (8)
Change in Fasting Glucose (mg/dL)
Fasting blood glucose levels will be measured in mg/dL at baseline and after the 8-week intervention.
Measured: From enrollment to the end of the treatment at 8 weeks
Change in Fasting Insulin (μIU/mL)
Fasting serum insulin levels will be measured in μIU/mL at baseline and after the 8-week intervention.
Measured: From enrollment to the end of the treatment at 8 weeks
Change in HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using fasting glucose and insulin values at baseline and after the 8-week intervention.
Measured: From enrollment to the end of the treatment at 8 weeks
Change in Total Cholesterol (mg/dL)
Serum Total Cholesterol will be measured in mg/dL at baseline and after the intervention.
Measured: From enrollment to the end of the treatment at 8 weeks
Change in Systolic and Diastolic Blood Pressure (mmHg)
Systolic and diastolic blood pressure will be measured using a standardized sphygmomanometer at baseline and after 8 weeks.
Measured: From enrollment to the end of the treatment at 8 weeks
Change in LDL Cholesterol (mg/dL)
Serum LDL cholesterol will be measured in mg/dL at baseline and after the intervention.
Measured: From enrollment to the end of the treatment at 8 weeks
Change in HDL Cholesterol (mg/dL)
Serum HDL cholesterol will be measured in mg/dL at baseline and after the intervention.
Measured: From enrollment to the end of the treatment at 8 weeks
Change in Triglycerides (mg/dL)
Serum triglyceride levels will be measured in mg/dL at baseline and after the intervention.
Measured: From enrollment to the end of the treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start21 Jul 2023
- Primary completion15 Oct 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Metabolic SyndromeStudies 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
- A total of 36 obese women aged between 20-49 years were randomly assigned to one of three groups: Early Time-Restricted Eating (eTRE; 08:00-16:00), Delayed Time-Restricted Eating (dTRE; 12:00-20:00), and a Control group (08:00-20:00). A one-day physical activity log was used to assess the participants' physical activity levels. Total energy expenditure was calculated for all participants, and a 25% energy restriction was applied to design individualized medical nutrition therapy.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SINEM BAYRAM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SINEM BAYRAM, Baskent University
- Investigators
- Sinem Bayram, Assoc. Prof., Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096505
- Sponsor's protocol ID
- SINEM_TRE_2025
- Other IDs
- KA23/107
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in time-restricted eating and metabolic syndrome. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters in Obese Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07096505
- Acronym / sponsor ID
- SINEM_TRE_2025
- Conditions
- Obesity and Metabolic Syndrome
- Keywords
- time restricted eating, obesity, intermittent fasting, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SINEM BAYRAMUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 31 Jul 2025 (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.
This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women.
Detailed description
This randomized controlled trial investigates the effects of time-restricted eating with different timing windows on metabolic syndrome parameters. A total of 36 sedentary obese women aged between 20-49 years were randomly assigned to one of three groups: Early Time-Restricted Eating (eTRE; 08:00-16:00), Delayed Time-Restricted Eating (dTRE; 12:00-20:00), and a Control group (08:00-20:00). Participants' physical activity levels were assessed using a one-day physical activity log. Total energy expenditure was calculated, and a 25% energy restriction was applied to create individualized medical nutrition therapy. Anthropometric measurements, body composition, and biochemical parameters were collected before and after the 8-week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of 36 obese women aged between 20-49 years were randomly assigned to one of three groups: Early Time-Restricted Eating (eTRE; 08:00-16:00), Delayed Time-Restricted Eating (dTRE; 12:00-20:00), and a Control group (08:00-20:00). A one-day physical activity log was used to assess the participants' physical activity levels. Total energy expenditure was calculated for all participants, and a 25% energy restriction was applied to design individualized medical nutrition therapy.
| Arm | Type | Receives |
|---|---|---|
| Early Time-Restricted Eating with Calorie Restriction | Experimental | Behavioral: Early time restricted eating with calorie restrictionParticipants ate all meals between 08:00 and 16:00 daily with calorie restriction diet for 8 weeks. |
| Delayed Time-Restricted Eating with Calorie Restriction | Experimental | Behavioral: Delayed Time Restricted Eating with calorie restrictionParticipants ate all meals between 12:00 and 20:00 daily with calorie restriction diet for 8 weeks. |
| control | Active comparator | Behavioral: Control group with calorie restrictionParticipants ate all meals between 08:00 and 20:00 daily with calorie restriction diet for 8 weeks. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI > 30 kg/m²
- Able to follow dietary protocols
- No chronic disease (T1DM, T2DM, cardiovascular disease, cancer)
- Not on a weight loss diet in the past 6 months
- No psychiatric disorder
Key exclusion criteria (7 listed)
- Menopausal women
- Cardiovascular disease
- Type 1 or Type 2 Diabetes
- Use of weight loss medications
- Pregnant or breastfeeding
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 |
|---|---|---|
| Early time restricted eating with calorie restrictionParticipants followed a diet with 25% energy restriction and an 8-hour eating window from 08:00 to 16:00. Dietary compliance was monitored by dietitian through food consumption records. | Behavioural | Early Time-Restricted Eating with Calorie Restriction |
| Delayed Time Restricted Eating with calorie restrictionParticipants followed a diet with 25% energy restriction and an 8-hour eating window from 12:00 to 20:00. Dietary compliance was monitored by dietitian through food consumption records. | Behavioural | Delayed Time-Restricted Eating with Calorie Restriction |
| Control group with calorie restrictionParticipants followed a diet with 25% energy restriction and a usual eating window from 08:00 to 20:00. Dietary compliance was monitored by dietitian through food consumption records. | Behavioural | control |
Primary outcome
Change in Body Weight (kg)
Time frame: from enrollment to the end of treatment at 8 weeks
Body weight will be measured in kilograms using standardized procedures at baseline and at the end of the 8-week intervention.
Change in Body Mass Index (BMI) (kg/m²)
Time frame: from enrollment to the end of treatment at 8 weeks
Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), will be recorded at baseline and at the end of the 8-week intervention.
Change in Waist Circumference (cm)
Time frame: from enrollment to the end of treatment at 8 weeks
Waist circumference will be measured in centimeters at baseline and at the end of the 8-week intervention using standardized anthropometric procedures.
8 secondary outcomes
Change in Fasting Glucose (mg/dL)
Time frame: From enrollment to the end of the treatment at 8 weeks
Change in Fasting Insulin (μIU/mL)
Time frame: From enrollment to the end of the treatment at 8 weeks
Change in HOMA-IR
Time frame: From enrollment to the end of the treatment at 8 weeks
Change in Total Cholesterol (mg/dL)
Time frame: From enrollment to the end of the treatment at 8 weeks
Change in Systolic and Diastolic Blood Pressure (mmHg)
Time frame: From enrollment to the end of the treatment at 8 weeks
Change in LDL Cholesterol (mg/dL)
Time frame: From enrollment to the end of the treatment at 8 weeks
Change in HDL Cholesterol (mg/dL)
Time frame: From enrollment to the end of the treatment at 8 weeks
Change in Triglycerides (mg/dL)
Time frame: From enrollment to the end of the treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in time-restricted eating and metabolic syndrome. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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. This study is not recruiting at the moment.
Sinem Bayram, Assoc. Prof. principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early time restricted eating with calorie restriction and Delayed Time Restricted Eating with calorie restriction in people with Obesity and Metabolic Syndrome, run by SINEM BAYRAM 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 31 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (kg) (time frame: from enrollment to the end of treatment at 8 weeks). The study lists 3 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 31 Jul 2025.