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

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: Recruiting
• Conditions: Time Restricted Eating
• Intervention / Treatment: Behavioral: early time restricted eating

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • University, Mississippi, United States, 38677
      • Recruiting
      • Department of Nutrition and Hospitality Management, University of Mississippi
      • Contact: Nadeeja Wijayatunga, MBBS, MPhil, PhD, RDN; Phone Number: 662-915-1351; Email: nadeejaw@olemiss.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular strength	Pre and post intervention testing of muscular strength using one-rep max	6-weeks
Muscular endurance	Pre and post intervention testing of muscular endurance using barbell bench press and squat.	6-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight (kg)	Pre and post intervention measures of body weight.	6-weeks
Hunger and satiety	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	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	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	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	Pre and post intervention measurements of macronutrients based on 24-hour food recall survey using the ASA24 software.	6-weeks
Adherence	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	Pre and post intervention measurements of body fat mass (kg).	6-weeks
Fat-free mass	pre and post intervention measurements of body fat-free mass (kg).	6-weeks
Body fat percentage	Pre and post intervention measurements of body fat percentage.	6-weeks

Collaborators and Investigators

• Sponsor: University of Mississippi, Oxford

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Estimated): June 16, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Intermittent fasting; Time restricted eating
• Other Study ID 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