An interventional study of TRE, ER, TRE+ER in Dyslipidemia and Obesity & Overweight, sponsored by Acibadem University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Acibadem University · Not applicable, Interventional, and Treatment
Background/Objectives: It is unclear whether the effects of time-restricted eating (TRE) on body composition and blood lipids are independent of energy restriction (ER), and whether combining the two confers additional benefit. Methods: In this prospective, 8-week, three-arm, parallel-group randomized controlled trial, 85 sedentary women aged 19-65 years with overweight/obesity and untreated dyslipidemia were allocated to TRE (16:8, ad libitum intake within a 12:00-20:00 window), ER (individually calculated diet providing approximately 500 kcal/day below total energy expenditure) or TRE + ER. Anthropometry and bioelectrical impedance analysis were performed at baseline, week 4 and week 8, and fasting biochemistry at baseline and week 8.
1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.
This study's enrollment of 56 is below the median of 100 across 861 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Acibadem University is the lead sponsor of 218 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
TRE alone
Other: TRE, ER, TRE+ER
TRE combined with ER
Other: TRE, ER, TRE+ER
ER alone
Other: TRE, ER, TRE+ER
The TRE arm followed a 16:8 protocol \[23\]: all food was consumed within an 8-h window from 12:00 to 20:00, and the remaining 16 h were spent fasting. Within the eating window participants ate ad libitum and received no guidance on food quantity or composition. During the 16-h fasting period only energy-free beverages (water, tea and coffee without added energy) were permitted. Participants in the TRE + ER arm followed the same 12:00-20:00 window while also adhering to the individually prescribed en-ergy-restricted diet described above.
Change in Body Weight (kg)
Body weight was assessed at baseline, week 4, and week 8. Body weight was measured in kilograms (kg)
Time frame: 8 weeks
Change in BMI (kg/m²).
Body Mass Index (BMI) was assessed at baseline, week 4, and week 8. BMI was calculated in kilograms per square meter (kg/m²).
Time frame: 8 weeks.
Change in Waist Circumference (cm)
Waist circumference was assessed at baseline, week 4, and week 8. Waist circumference was measured in centimeters (cm).
Time frame: 8 weeks.
Change in Hip Circumference (cm)
Hip circumference was assessed at baseline, week 4, and week 8. Hip circumference was measured in centimeters (cm).
Time frame: 8 weeks.
Change in Fat Mass (kg)
Fat mass was assessed at baseline, week 4, and week 8. Fat mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Time frame: 8 weeks.
Change in Fat-Free Mass (kg)
Fat-free mass was assessed at baseline, week 4, and week 8. Fat-free mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Time frame: 8 weeks.
Change in Skeletal Muscle Mass (kg)
Skeletal muscle mass was assessed at baseline, week 4, and week 8. Skeletal muscle mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Time frame: 8 weeks
Change in Total Cholesterol (mg/dL)
Total cholesterol was assessed at baseline and week 8. Total cholesterol was measured in milligrams per deciliter (mg/dL).
Time frame: 8 weeks
Change in LDL Cholesterol (mg/dL)
LDL cholesterol was assessed at baseline and week 8. LDL cholesterol was measured in milligrams per deciliter (mg/dL).
Time frame: 8 weeks
Change in HDL Cholesterol (mg/dL)
HDL cholesterol was assessed at baseline and week 8. HDL cholesterol was measured in milligrams per deciliter (mg/dL).
Time frame: 8 weeks
Change in Triglycerides (mg/dL)
Triglycerides was assessed at baseline and week 8. Triglycerides was measured in milligrams per deciliter (mg/dL).
Time frame: 8 weeks
Change in HbA1C (%)
HbA1C was assessed at baseline and week 8. HbA1C was measured as a percentage (%).
Time frame: 8 weeks.
Change in Waist-to-Hip Ratio
Waist-to-hip ratio was assessed at baseline, week 4, and week 8.
Time frame: 8 weeks
Change in Body Fat Percentage (%)
Body fat percentage was assessed at baseline, week 4, and week 8. Body fat percentage was measured as a percentage (%).
Time frame: 8 weeks
Change in Fat-Free Mass Percentage (%)
Fat-free mass percentage was assessed at baseline, week 4, and week 8. Fat-free mass percentage was measured as a percentage (%)
Time frame: 8 weeks
Change in VLDL Cholesterol (mg/dL)
VLDL cholesterol was assessed at baseline, and week 8. VLDL cholesterol was measured in milligrams per deciliter (mg/dL)
Time frame: 8 weeks
Change in Fasting Plasma Glucose (mg/dL)
Fasting plasma glucose was assessed at baseline and week 8. Fasting plasma glucose was measured in milligrams per deciliter (mg/dL).
Time frame: 8 weeks
Change in AST (U/L)
AST was assessed at baseline and week 8. AST was measured in units per liter (U/L)
Time frame: 8 weeks
Change in ALT (U/L)
ALT was assessed at baseline and week 8. ALT was measured in units per liter (U/L)
Time frame: 8 weeks
Change in TIBC (μg)
Total iron-binding capacity was assessed at baseline and week 8.Total iron-binding capacity was measured in micrograms per deciliter (μg/dL).
Time frame: 8 weeks
Change in Ferritin (ng/mL)
Ferritin was assessed at baseline and week 8. Ferritin was measured in nanogram per milliliter (ng/mL)
Time frame: 8 weeks
Change in Creatinine (mg/dL)
Creatinine was assessed at baseline and week 8. Creatinine was measured in milligrams per deciliter (mg/dL).
Time frame: 8 weeks
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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