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

Effects of Early and Delayed Time-Restricted Eating on Body Weight and Metabolic Parameters in Adults With Overweight and Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight and Obesity; Time Restricted Feeding; Intermittent Fasting
• Intervention / Treatment: Behavioral: Dietary Approach

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90690-200
      • Universidade Federal do Rio Grande do Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Time-Restricted Eating; 8-hour eating window between 08:00 and 16:00	Behavioral: Dietary Approach; Dietary approaches with energy restriction performed at different times of the day.
Experimental: Delayed Time-Restricted Eating; 8-hour eating window between 12:00 and 20:00	Behavioral: Dietary Approach; Dietary approaches with energy restriction performed at different times of the day.
Experimental: Control; 12-hour eating window between 08:00 and 20:00	Behavioral: Dietary Approach; Dietary approaches with energy restriction performed at different times of the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin resistance (indices)	Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).	Change from baseline. Measured at baseline and after 8 weeks.
Fasting insulin levels (µIU/mL)	Measured by enzyme-Linked Immunosorbent Assay	Change from baseline. Measured at baseline and after 8 weeks.
Fasting glucose levels (mg/dL)	Measured by colorimetric method	Change from baseline. Measured at baseline and after 8 weeks.
Insulin Sensitivity (indices)	Including but not limited to the Matsuda index	Change from baseline. Measured at baseline and after 8 weeks.
Glucose tolerance	Measured by oral glucose tolerance test (OGTT; 0,30,60,90, and 120 min)	Change from baseline. Measured at baseline and after 8 weeks.
Fasting lipid profile levels (mg/dL)	Measured by colorimetric method	Change from baseline. Measured at baseline and after 8 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): May 12, 2020
• Study Completion (Actual): May 12, 2020

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 22, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: TRE_UFRGS#

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No