Clinical trial NCT05922475: Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training
Official title: Neither Pre-sleep Nor Post-exercise Protein Consumption Influences Resistance Exercise Training Adaptations in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Exercise
Hypertrophy
Strength
Power
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 32
Sex: MALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effects of protein consumption before sleep or immediately after exercise during 12 weeks of resistance exercise training in older adults. The main questions it aims to answer are:

Are there differences in muscle growth or strength during 12 weeks of resistance training when 40 grams of protein is consumed either before sleep or immediately after exercise? Are there differences in cognitive performance during 12 weeks of resistance training when 40 grams of protein is consumed either before sleep or immediately after exercise?

This study is a randomized double-blind placebo-controlled study. Participants will be randomly allocated into 1 of 3 groups. All three groups will perform the same 12-week resistance exercise training program two times per week and consume 40 g of protein: 1) Immediately post-exercise, 2) 30 minutes prior to sleep, or 3) no supplemental protein (control). Test of muscle growth and strength, and cognitive performance will be measure before, during, and after the exercise training program.

Researchers will compare the 3 conditions to determine if consume protein after exercise or before sleep during 12 weeks of resistance exercise training affects muscle growth and strength, and cognitive performance.


Eligibility criteria: Inclusion Criteria:

* Male between 60-75 years old at the time of enrollment.

Exclusion Criteria:

* Diagnosis of cardiac or peripheral vascular disease
* Stroke, kidney dysfunction
* Metabolic disease
* Uncontrolled hypertension
* Orthopedic limitations
* Skeletal muscle complications
* Milk allergy
* Psychiatric conditions
* Use of psychotropic drugs
* Cognitive impairment (scoring 26 points or less on the Montreal Cognitive Assessment)
* Participation in a structured regular exercise program within the past 6 months
* Actively attempting to increase or decrease body mass
* Body mass index (BMI) of ≥ 35 kg/m2

Primary outcomes:
measure: Muscle thickness
timeFrame: Week 0, 6, and 12
Secondary outcomes:
measure: Maximum muscular strength
timeFrame: Week 0, 6, and 12
measure: Muscle power
timeFrame: Week 0, 6, and 12
measure: Cognitive performance
timeFrame: Week 0 and 12
measure: Measures associated appetite
timeFrame: Week 0, 6, and 12
measure: Total sleep time
timeFrame: Week 0 and 12
measure: Sleep latency
timeFrame: Week 0 and 12
measure: Measures associated with sleep
timeFrame: Week 0 and 12
measure: Nitrogen balance
timeFrame: Week 0 and 12
measure: Free insulin-like growth factor 1
timeFrame: Week 0 and 12
measure: Mood
timeFrame: Week 0 and 12
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Student
name: Alex O Klemp, PhD
role: PRINCIPAL_INVESTIGATOR
References: