Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity

Not Applicable

Completed

• Conditions: Obesity; Time Restricted Feeding; Intermittent Fasting; Overweight and Obesity
• Interventions: Behavioral: Dietary Approach

• Registration Number: NCT04647149
• Lead Sponsor: Federal University of Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-03
• Primary Completion: 2020-05-12
• Study Completion: 2020-05-12
• Status Verified: 2020-11
• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-22
• Last Update Submitted: 2020-11-22
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Time-Restricted Eating	Dietary Approach	8-hour eating window between 08:00 and 16:00
Control	Dietary Approach	12-hour eating window between 08:00 and 20:00
Delayed Time-Restricted Eating	Dietary Approach	8-hour eating window between 12:00 and 20:00

Primary Outcome Measures

Name	Time	Method
Fasting lipid profile levels (mg/dL)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by colorimetric method
Insulin resistance (indices)	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)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by enzyme-Linked Immunosorbent Assay
Fasting glucose levels (mg/dL)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by colorimetric method
Insulin Sensitivity (indices)	Change from baseline. Measured at baseline and after 8 weeks.	Including but not limited to the Matsuda index
Glucose tolerance	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 Outcome Measures

Name	Time	Method
Quality of sleep	Change from baseline. Measured at baseline and after 8 weeks.	Measured by Pittsburgh Sleep Quality Index Questionnaire. Higher scores indicate worse sleep quality.
Risk of binge eating	Change from baseline. Measured at baseline and after 8 weeks.	Measured by binge eating scale. Higher scores indicate greater risk of binge eating.
Fat Free Mass (kg)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Body Weight (kg)	Change from baseline. Measured at baseline and after 4, and 8 weeks.	Measured on a digital scale.
Bone Mineral Content (kg)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Substrate Oxidation (respiratory exchange ratio)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by indirect calorimetry under resting and fasting conditions.
β cell function (indices)	Change from baseline. Measured at baseline and after 8 weeks.	Including but not limited to HOMA-BETA
Body Mass Index (kg/m^2)	Change from baseline. Measured at baseline and after 8 weeks.	Calculated from weight in kilograms divided by height in meters squared.
Fat Mass (kg)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Fat Percentage (%)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by Dual-energy X-ray Absorptiometry under fasting condition.
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.	Measured by indirect calorimetry under resting and fasting conditions.
Peak oxygen consumption (mL/min and mL/kg/min)	Change from baseline. Measured at baseline and after 8 weeks.	Measured by an open-circuit spirometry system
Subjective appetite parameters (hunger, fullness, prospective food consumption, and desire to eat).	Change from baseline. Measured at baseline and after 8 weeks.	Measured by visual analog scale.The scale range is 0-100 mm and each end represent the extremes.

Trial Locations

Locations (1)

Universidade Federal do Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil