Effects of Early Time Restricted Eating on Muscle Performance in Resistance Trained Individuals

June 8, 2023 updated by: University of Mississippi, Oxford

Effects of 6-weeks of Early Time Restricted Eating on Muscle Performance in Resistance Trained Individuals

A randomized controlled trial to determine the effectiveness of early time-restricted eating on muscle performance and body composition in active, resistance trained adults. Two parallel groups will be randomly assigned to either the early time-restricted eating or a control group. All participants will be asked to maintain their usual exercise routines during the 6 week intervention period. Muscle strength and endurance are the primary outcomes. Body composition (body weight, fat mass, fat-free mass and percent body fat), hunger and satiety ratings, sleep quality, energy intake, diet quality, macronutrient composition and adherence are secondary outcome measures.

Study Overview

Status

Status

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

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 (Estimated)

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.
40

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

  • United States
    • Mississippi
      • University, Mississippi, United States, 38677
        • Recruiting
        • Department of Nutrition and Hospitality Management, University of Mississippi
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults between 18 - 50 years
  • Performing resistance training at least twice per week (for ≥1 yr)
  • BMI ≥ 18.5

Exclusion Criteria:

  • Currently sedentary or not engaged in resistance training.
  • Major surgeries in muscles/joints during the past 3 months
  • BMI < 18.5
  • Ineligible to engage in physical activity according to 2022 Physical Activity Readiness Questionnaire for everyone (PAR-Q+)
  • Take anabolic steroids or on hormone replacement therapy.
  • Current smoker.
  • Following restrictive diets (Vegan, vegetarian, intermittent fasting, Paleo, calorie restriction, keto/ low carbohydrate diet or any other restrictive diets)
  • Active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer).
  • Musculoskeletal disorders
  • Diagnosed with cardiovascular disease including myocardial infarction, heart surgery, heart failure and had a heart transplant.
  • Have pacemaker or metal implants
  • Diagnosed diabetes (type 1 or 2).
  • Diagnosed hypertension or high blood pressure (>130/90).
  • Diagnosed eating disorder or score ≥ 20 on Eating Attitudes Test -26 (EAT26) survey
  • Missing limbs/ have prosthetics
  • Had surgery in joints/muscle in the past year.
  • Received medical advise against exercising due to medical reasons.
  • On medication for conditions related to the thyroid gland
  • Unwilling to commit for a 7-week study
  • Likely to move away from participating clinic before trial completed
  • Unable or unwilling to give informed consent
  • Another household member is a participant or staff member in the trial
  • Unwilling to accept treatment assignment by randomization
  • Current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial
  • Pregnant or < 6 months since giving birth.
  • Any other condition which, in opinion of investigators, that would adversely affect conduct of the trial.

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: None (Open Label)

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
The Early Time Restricted Eating (eTRE) group will be asked to consume calorie containing food or drinks only between 9am to 5pm, daily. At other times they are to avoid consuming any calorie containing food or drinks.
Behavioral: early time restricted eating
The intervention group will eat in a prescribed daily feeding window (9am-5pm) and follow their normal exercise and resistance training routines. We will allow up till +/-1 hour for the eating window start and end times while aiming for an 8 hour eating window.
No Intervention: Control
The Control group will follow their usual eating routine.

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
Muscular strength
Time Frame: 6-weeks
Pre and post intervention testing of muscular strength using one-rep max
6-weeks
Muscular endurance
Time Frame: 6-weeks
Pre and post intervention testing of muscular endurance using barbell bench press and squat.
6-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
Body weight (kg)
Time Frame: 6-weeks
Pre and post intervention measures of body weight.
6-weeks
Hunger and satiety
Time Frame: 6-weeks
Pre and post intervention subjective measure of hunger and satiety with the use of a Hunger and Satiety Visual Analog Scale (minimum value zero, maximum value 10). Higher the score, the more hungry/ less satiated one is.
6-weeks
Sleep quality
Time Frame: 6-weeks
Pre and post intervention measure of subjective sleep quality by use of Pittsburgh Sleep Quality Scale. (each question can be scored from 0-3, then an aggregate score of the whole survey can range from 0-21; The higher the score the worst the sleep quality).
6-weeks
Total calorie intake
Time Frame: 6-weeks
Pre and post intervention measurements of calorie intake based on 24-hour food recall survey using the Automated Self-Administered 24-hour (ASA24) software.
6-weeks
Diet Quality
Time Frame: 6-weeks
Pre and post intervention measurements of diet quality based on 24-hour food recall survey using the ASA24 software and Healthy Eating Index.
6-weeks
Diet macronutrient composition
Time Frame: 6-weeks
Pre and post intervention measurements of macronutrients based on 24-hour food recall survey using the ASA24 software.
6-weeks
Adherence
Time Frame: 6-weeks
Percent of days during the 6-week trial when eTRE was adhered to as recommended. This will be recorded by the participants daily throughout the entire study.
6-weeks
Fat mass
Time Frame: 6-weeks
Pre and post intervention measurements of body fat mass (kg).
6-weeks
Fat-free mass
Time Frame: 6-weeks
pre and post intervention measurements of body fat-free mass (kg).
6-weeks
Body fat percentage
Time Frame: 6-weeks
Pre and post intervention measurements of body fat percentage.
6-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.
University of Mississippi, Oxford

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.
February 20, 2023

Primary Completion (Estimated)

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.
December 31, 2023

Study Completion (Estimated)

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 31, 2024

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).
March 21, 2023

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.
June 8, 2023

First Posted (Estimated)

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.
June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
June 16, 2023

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.
June 8, 2023

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.
June 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 23-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share the de-identified participant data used in the published manuscript/s by depositing these data in the Open Science Framework (OSF) repository. The data shared will include the sociodemographic data and the outcomes published in the manuscripts. The protocol and statistical analysis plan will be shared as supplementary material through the journal where the study if published, if allowed.

IPD Sharing Time Frame

We agree to deposit outcome data into the OSF repository as soon as possible but no later than within two years after the last publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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