The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters
2 other identifiers
interventional
36
1 country
1
Brief Summary
This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedFirst Submitted
Initial submission to the registry
July 17, 2025
CompletedFirst Posted
Study publicly available on registry
July 31, 2025
CompletedJuly 31, 2025
July 1, 2025
1.2 years
July 17, 2025
July 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
from enrollment to the end of treatment at 8 weeks
Secondary Outcomes (8)
Change in Fasting Glucose (mg/dL)
From enrollment to the end of the treatment at 8 weeks
Change in Fasting Insulin (μIU/mL)
From enrollment to the end of the treatment at 8 weeks
Change in HOMA-IR
From enrollment to the end of the treatment at 8 weeks
Change in Total Cholesterol (mg/dL)
From enrollment to the end of the treatment at 8 weeks
Change in Systolic and Diastolic Blood Pressure (mmHg)
From enrollment to the end of the treatment at 8 weeks
- +3 more secondary outcomes
Study Arms (3)
Early Time-Restricted Eating with Calorie Restriction
EXPERIMENTALParticipants ate all meals between 08:00 and 16:00 daily with calorie restriction diet for 8 weeks.
Delayed Time-Restricted Eating with Calorie Restriction
EXPERIMENTALParticipants ate all meals between 12:00 and 20:00 daily with calorie restriction diet for 8 weeks.
control
ACTIVE COMPARATORParticipants ate all meals between 08:00 and 20:00 daily with calorie restriction diet for 8 weeks.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Menopausal women
- Cardiovascular disease
- Type 1 or Type 2 Diabetes
- Use of weight loss medications
- Pregnant or breastfeeding
- Smoking
- Shift workers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SINEM BAYRAMlead
Study Sites (1)
Baskent University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sinem Bayram, Assoc. Prof.
Baskent University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
July 17, 2025
First Posted
July 31, 2025
Study Start
July 21, 2023
Primary Completion
October 15, 2024
Study Completion
December 15, 2024
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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.