NCT05908201

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

March 21, 2023

Last Update Submit

June 8, 2023

Conditions

Keywords

Intermittent fastingTime restricted eating

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Body weight (kg)

    6-weeks

  • Hunger and satiety

    6-weeks

  • Sleep quality

    6-weeks

  • Total calorie intake

    6-weeks

  • Diet Quality

    6-weeks

  • +5 more secondary outcomes

Study Arms (2)

early time-restricted eating

EXPERIMENTAL

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

Control

NO INTERVENTION

The Control group will follow their usual eating routine.

Interventions

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.

early time-restricted eating

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition and Hospitality Management, University of Mississippi

University, Mississippi, 38677, United States

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

June 18, 2023

Study Start

February 20, 2023

Primary Completion

December 31, 2023

Study Completion

May 31, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.

Locations