Obesity and Metabolic Syndrome
Conditions
Keywords
time restricted eating, obesity, intermittent fasting, randomized controlled trial
Brief summary
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.
Interventions
BEHAVIORALEarly time restricted eating with calorie restriction
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.
BEHAVIORALDelayed Time Restricted Eating with calorie restriction
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.
BEHAVIORALControl group with calorie restriction
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.
Sponsors
SINEM BAYRAM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Menopausal women * Cardiovascular disease * Type 1 or Type 2 Diabetes * Use of weight loss medications * Pregnant or breastfeeding * Smoking * Shift workers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (kg) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cholesterol (mg/dL) | From enrollment to the end of the treatment at 8 weeks | Serum Total Cholesterol will be measured in mg/dL at baseline and after the intervention. |
| Change in Systolic and Diastolic Blood Pressure (mmHg) | From enrollment to the end of the treatment at 8 weeks | Systolic and diastolic blood pressure will be measured using a standardized sphygmomanometer at baseline and after 8 weeks. |
| Change in Fasting Glucose (mg/dL) | From enrollment to the end of the treatment at 8 weeks | Fasting blood glucose levels will be measured in mg/dL at baseline and after the 8-week intervention. |
| Change in HDL Cholesterol (mg/dL) | From enrollment to the end of the treatment at 8 weeks | Serum HDL cholesterol will be measured in mg/dL at baseline and after the intervention. |
| Change in Triglycerides (mg/dL) | From enrollment to the end of the treatment at 8 weeks | Serum triglyceride levels will be measured in mg/dL at baseline and after the intervention. |
| Change in LDL Cholesterol (mg/dL) | From enrollment to the end of the treatment at 8 weeks | Serum LDL cholesterol will be measured in mg/dL at baseline and after the intervention. |
| Change in Fasting Insulin (μIU/mL) | From enrollment to the end of the treatment at 8 weeks | Fasting serum insulin levels will be measured in μIU/mL at baseline and after the 8-week intervention. |
| Change in HOMA-IR | From enrollment to the end of the treatment at 8 weeks | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed