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

NCT04647149 | Completed

• 1 other identifier: TRE_UFRGS#
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Time Restricted Feeding; Intermittent Fasting; Obesity; Overweight and Obesity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

• β cell function (indices)

  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.

• 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 8 weeks.

Study Arms (3)

Early Time-Restricted Eating

EXPERIMENTAL

8-hour eating window between 08:00 and 16:00

Behavioral: Dietary Approach

Delayed Time-Restricted Eating

EXPERIMENTAL

8-hour eating window between 12:00 and 20:00

Behavioral: Dietary Approach

Control

EXPERIMENTAL

12-hour eating window between 08:00 and 20:00

Behavioral: Dietary Approach

Interventions

Dietary Approach BEHAVIORAL

Dietary approaches with energy restriction performed at different times of the day.

Control; Delayed Time-Restricted Eating; Early Time-Restricted Eating

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

MeSH Terms

Conditions

Intermittent Fasting; Obesity; Overweight

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alvaro Reischak-Oliveira

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 30, 2020
• Study Start: September 3, 2019
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

BR (1)