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

Time Restricted Eating Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908201
• Other study ID #: 23-030
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: University of Mississippi, Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Time Restricted Eating

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Nutrition and Hospitality Management, University of Mississippi	University	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi, Oxford

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular strength	Pre and post intervention testing of muscular strength using one-rep max	6-weeks
Primary	Muscular endurance	Pre and post intervention testing of muscular endurance using barbell bench press and squat.	6-weeks
Secondary	Body weight (kg)	Pre and post intervention measures of body weight.	6-weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Diet macronutrient composition	Pre and post intervention measurements of macronutrients based on 24-hour food recall survey using the ASA24 software.	6-weeks
Secondary	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
Secondary	Fat mass	Pre and post intervention measurements of body fat mass (kg).	6-weeks
Secondary	Fat-free mass	pre and post intervention measurements of body fat-free mass (kg).	6-weeks
Secondary	Body fat percentage	Pre and post intervention measurements of body fat percentage.	6-weeks