Clinical trial NCT05908201: Effects of Early Time Restricted Eating on Muscle Performance in Resistance Trained Individuals
Official title: Effects of 6-weeks of Early Time Restricted Eating on Muscle Performance in Resistance Trained Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Time Restricted Eating
Keywords: Intermittent fasting
Time restricted eating
Lead sponsor: University of Mississippi, Oxford
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscular strength
timeFrame: 6-weeks
measure: Muscular endurance
timeFrame: 6-weeks
Secondary outcomes:
measure: Body weight (kg)
timeFrame: 6-weeks
measure: Hunger and satiety
timeFrame: 6-weeks
measure: Sleep quality
timeFrame: 6-weeks
measure: Total calorie intake
timeFrame: 6-weeks
measure: Diet Quality
timeFrame: 6-weeks
measure: Diet macronutrient composition
timeFrame: 6-weeks
measure: Adherence
timeFrame: 6-weeks
measure: Fat mass
timeFrame: 6-weeks
measure: Fat-free mass
timeFrame: 6-weeks
measure: Body fat percentage
timeFrame: 6-weeks
Other outcomes:
Locations:
city: University
country: United States
facility: Department of Nutrition and Hospitality Management, University of Mississippi
state: Mississippi
Study officials:
References: