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

November 22, 2020 updated by: Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Change from baseline. Measured at baseline and after 8 weeks.
Fasting insulin levels (µIU/mL)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by enzyme-Linked Immunosorbent Assay
Change from baseline. Measured at baseline and after 8 weeks.
Fasting glucose levels (mg/dL)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by colorimetric method
Change from baseline. Measured at baseline and after 8 weeks.
Insulin Sensitivity (indices)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Including but not limited to the Matsuda index
Change from baseline. Measured at baseline and after 8 weeks.
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)
Change from baseline. Measured at baseline and after 8 weeks.
Fasting lipid profile levels (mg/dL)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by colorimetric method
Change from baseline. Measured at baseline and after 8 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
β cell function (indices)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Including but not limited to HOMA-BETA
Change from baseline. Measured at baseline and after 8 weeks.
Fat Mass (kg)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Change from baseline. Measured at baseline and after 8 weeks.
Fat Percentage (%)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Change from baseline. Measured at baseline and after 8 weeks.
Fat Free Mass (kg)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Time Frame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Measured on a digital scale.
Change from baseline. Measured at baseline and after 4, and 8 weeks.
Bone Mineral Content (kg)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
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)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
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)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Change from baseline. Measured at baseline and after 8 weeks.
Resting metabolic rate (Kcal/day)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by indirect calorimetry under resting and fasting conditions.
Change from baseline. Measured at baseline and after 8 weeks.
Substrate Oxidation (respiratory exchange ratio)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
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)
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by an open-circuit spirometry system
Change from baseline. Measured at baseline and after 8 weeks.
Quality of sleep
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
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
Time Frame: Change from baseline. Measured at baseline and after 8 weeks.
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).
Time Frame: 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.
Change from baseline. Measured at baseline and after 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Rio Grande do Sul

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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