search
Back to results

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

Primary Purpose

Time Restricted Feeding, Intermittent Fasting, Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dietary Approach
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Time Restricted Feeding

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Early Time-Restricted Eating

Delayed Time-Restricted Eating

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

β cell function (indices)
Including but not limited to HOMA-BETA
Fat Mass (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Fat Percentage (%)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Fat Free Mass (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Body Weight (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Body Weight (kg)
Measured on a digital scale.
Bone Mineral Content (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Body Mass Index (kg/m^2)
Calculated from weight in kilograms divided by height in meters squared.
Fasting ketones (β-hydroxybutyrate) levels (mmol/L)
Resting metabolic rate (Kcal/day)
Measured by indirect calorimetry under resting and fasting conditions.
Substrate Oxidation (respiratory exchange ratio)
Measured by indirect calorimetry under resting and fasting conditions.
Peak oxygen consumption (mL/min and mL/kg/min)
Measured by an open-circuit spirometry system
Quality of sleep
Measured by Pittsburgh Sleep Quality Index Questionnaire. Higher scores indicate worse sleep quality.
Risk of binge eating
Measured by binge eating scale. Higher scores indicate greater risk of binge eating.
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.

Full Information

First Posted
November 14, 2020
Last Updated
November 22, 2020
Sponsor
Federal University of Rio Grande do Sul
search

1. Study Identification

Unique Protocol Identification Number
NCT04647149
Brief Title
Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity
Official Title
Effects of Early and Delayed Time-Restricted Eating on Body Weight and Metabolic Parameters in Adults With Overweight and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
May 12, 2020 (Actual)
Study Completion Date
May 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time Restricted Feeding, Intermittent Fasting, Obesity, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Time-Restricted Eating
Arm Type
Experimental
Arm Description
8-hour eating window between 08:00 and 16:00
Arm Title
Delayed Time-Restricted Eating
Arm Type
Experimental
Arm Description
8-hour eating window between 12:00 and 20:00
Arm Title
Control
Arm Type
Experimental
Arm Description
12-hour eating window between 08:00 and 20:00
Intervention Type
Behavioral
Intervention Name(s)
Dietary Approach
Intervention Description
Dietary approaches with energy restriction performed at different times of the day.
Primary Outcome Measure Information:
Title
Insulin resistance (indices)
Description
Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Fasting insulin levels (µIU/mL)
Description
Measured by enzyme-Linked Immunosorbent Assay
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Fasting glucose levels (mg/dL)
Description
Measured by colorimetric method
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Insulin Sensitivity (indices)
Description
Including but not limited to the Matsuda index
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Glucose tolerance
Description
Measured by oral glucose tolerance test (OGTT; 0,30,60,90, and 120 min)
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Fasting lipid profile levels (mg/dL)
Description
Measured by colorimetric method
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Secondary Outcome Measure Information:
Title
β cell function (indices)
Description
Including but not limited to HOMA-BETA
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Fat Mass (kg)
Description
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Fat Percentage (%)
Description
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Fat Free Mass (kg)
Description
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Body Weight (kg)
Description
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Body Weight (kg)
Description
Measured on a digital scale.
Time Frame
Change from baseline. Measured at baseline and after 4, and 8 weeks.
Title
Bone Mineral Content (kg)
Description
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Body Mass Index (kg/m^2)
Description
Calculated from weight in kilograms divided by height in meters squared.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Fasting ketones (β-hydroxybutyrate) levels (mmol/L)
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Resting metabolic rate (Kcal/day)
Description
Measured by indirect calorimetry under resting and fasting conditions.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Substrate Oxidation (respiratory exchange ratio)
Description
Measured by indirect calorimetry under resting and fasting conditions.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Peak oxygen consumption (mL/min and mL/kg/min)
Description
Measured by an open-circuit spirometry system
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Quality of sleep
Description
Measured by Pittsburgh Sleep Quality Index Questionnaire. Higher scores indicate worse sleep quality.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Risk of binge eating
Description
Measured by binge eating scale. Higher scores indicate greater risk of binge eating.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.
Title
Subjective appetite parameters (hunger, fullness, prospective food consumption, and desire to eat).
Description
Measured by visual analog scale.The scale range is 0-100 mm and each end represent the extremes.
Time Frame
Change from baseline. Measured at baseline and after 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Reischak-Oliveira
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90690-200
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs