Effects of Early and Delayed Time-Restricted Eating on Body Weight and Metabolic Parameters in Adults With Overweight and Obesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Time Restricted Feeding
- Sponsor
- Federal University of Rio Grande do Sul
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Fasting lipid profile levels (mg/dL)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and some cardiometabolic risk factors have been reported. However, there is a lack of randomized clinical trials that directly investigate the effect of TRE at different times of the day (early vs. delayed) in individuals with overweight and obesity. The present study investigates the effects of 8 weeks of TRE performed at different moments of the day on body composition and cardiometabolic parameters in adults with overweight and obesity.
Investigators
Alvaro Reischak-Oliveira
Professor
Federal University of Rio Grande do Sul
Eligibility Criteria
Inclusion Criteria
- •Male and female;
- •Body mass index (BMI) between 25 and 34.9 kg/m²;
- •Age between 20 and 40 years;
- •Not engaged in any structured exercise program;
- •Weight stable for \~3 months prior to the beginning of the study;
- •Able to give written informed consent.
Exclusion Criteria
- •Current smoker;
- •Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc);
- •Current treatment with medication or supplements which significantly affect the main studied variables;
- •Night-shift workers;
- •Night eating syndrome;
- •Irregular sleep patterns;
- •For women: pregnancy, planned pregnancy (within the study period), lactating or menopause;
- •Habitual fasting window \>16 hours;
- •Concomitant participation in other studies.
Outcomes
Primary Outcomes
Fasting lipid profile levels (mg/dL)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by colorimetric method
Insulin resistance (indices)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Fasting insulin levels (µIU/mL)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by enzyme-Linked Immunosorbent Assay
Fasting glucose levels (mg/dL)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by colorimetric method
Insulin Sensitivity (indices)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Including but not limited to the Matsuda index
Glucose tolerance
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by oral glucose tolerance test (OGTT; 0,30,60,90, and 120 min)
Secondary Outcomes
- Quality of sleep(Change from baseline. Measured at baseline and after 8 weeks.)
- Risk of binge eating(Change from baseline. Measured at baseline and after 8 weeks.)
- Fat Free Mass (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
- Body Weight (kg)(Change from baseline. Measured at baseline and after 4, and 8 weeks.)
- Bone Mineral Content (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
- Substrate Oxidation (respiratory exchange ratio)(Change from baseline. Measured at baseline and after 8 weeks.)
- β cell function (indices)(Change from baseline. Measured at baseline and after 8 weeks.)
- Body Mass Index (kg/m^2)(Change from baseline. Measured at baseline and after 8 weeks.)
- Fat Mass (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
- Fat Percentage (%)(Change from baseline. Measured at baseline and after 8 weeks.)
- Fasting ketones (β-hydroxybutyrate) levels (mmol/L)(Change from baseline. Measured at baseline and after 8 weeks.)
- Resting metabolic rate (Kcal/day)(Change from baseline. Measured at baseline and after 8 weeks.)
- Peak oxygen consumption (mL/min and mL/kg/min)(Change from baseline. Measured at baseline and after 8 weeks.)
- Subjective appetite parameters (hunger, fullness, prospective food consumption, and desire to eat).(Change from baseline. Measured at baseline and after 8 weeks.)