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

Sponsor
University of Mississippi, Oxford (Other)
Overall Status
Recruiting
CT.gov ID
NCT05908201
Collaborator
(none)
40
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: early time restricted eating
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of 6-weeks of Early Time Restricted Eating on Muscle Performance in Resistance Trained Individuals
Actual Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Muscular strength [6-weeks]

    Pre and post intervention testing of muscular strength using one-rep max

  2. Muscular endurance [6-weeks]

    Pre and post intervention testing of muscular endurance using barbell bench press and squat.

Secondary Outcome Measures

  1. Body weight (kg) [6-weeks]

    Pre and post intervention measures of body weight.

  2. Hunger and satiety [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.

  3. Sleep quality [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).

  4. Total calorie intake [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.

  5. Diet Quality [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. Diet macronutrient composition [6-weeks]

    Pre and post intervention measurements of macronutrients based on 24-hour food recall survey using the ASA24 software.

  7. Adherence [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.

  8. Fat mass [6-weeks]

    Pre and post intervention measurements of body fat mass (kg).

  9. Fat-free mass [6-weeks]

    pre and post intervention measurements of body fat-free mass (kg).

  10. Body fat percentage [6-weeks]

    Pre and post intervention measurements of body fat percentage.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nutrition and Hospitality Management, University of Mississippi University Mississippi United States 38677

Sponsors and Collaborators

  • University of Mississippi, Oxford

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Mississippi, Oxford
ClinicalTrials.gov Identifier:
NCT05908201
Other Study ID Numbers:
  • 23-030
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Mississippi, Oxford

Study Results

No Results Posted as of Jun 18, 2023