Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training

Study Overview
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Brief Summary
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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.

Official Title
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Neither Pre-sleep Nor Post-exercise Protein Consumption Influences Resistance Exercise Training Adaptations in Older Adults

Conditions
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Aging

Intervention / Treatment
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* Dietary Supplement: Protein
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-exercise protein<br>Consumed 40 g of supplemental protein immediately after exercise sessions and in between breakfast and lunch on non-exercise days. | Dietary Supplement: Protein<br>* Post-exercise protein group consumed protein immediately after exercise sessions. Pre-sleep protein group consumed protein 30 minutes before sleep.<br>|
| Experimental: Pre-sleep protein<br>Consumed 40 g of supplemental protein 30 minutes before sleep every day. | Dietary Supplement: Protein<br>* Post-exercise protein group consumed protein immediately after exercise sessions. Pre-sleep protein group consumed protein 30 minutes before sleep.<br>|
| Placebo Comparator: Resistance exercise training only<br>Did not consume supplemental protein. | Other: Placebo<br>* Resistance exercise training only group did not consume supplemental protein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle thickness | Change in muscle thickness of the quadriceps muscles in centimeters from week 0 (baseline) to week 6 (midpoint) to week 12 (end of study). | Week 0, 6, and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum muscular strength | Changes in strength of the chest press and leg press exercises in kilograms from week 0 (baseline) to week 6 (midpoint) to week 12 (end of study). | Week 0, 6, and 12 | 
| Muscle power | Changes in power (Watts) during a sit-to-stand task from week 0 (baseline) to week 6 (midpoint) to week 12 (end of study). | Week 0, 6, and 12 | 
| Cognitive performance | Changes in the number of correct responses during the digit symbol substitution task and pattern comparison tests from week 0 (baseline) to week 12 (end of study). | Week 0 and 12 | 
| Measures associated appetite | Changes in subjective measures of hunger, satiety, and desire to eat on a 0-100 millimeter (higher values indicating stronger feeling) visual analog scale from week 0 (baseline) to week 6 (midpoint) to week 12 (end of study). | Week 0, 6, and 12 | 
| Total sleep time | Changes in actigraphy watch measured total sleep time in hours from week 0 (baseline) to week 12 (end of study). | Week 0 and 12 | 
| Sleep latency | Changes in actigraphy watch measured sleep latency in minutes from week 0 (baseline) to week 12 (end of study). | Week 0 and 12 | 
| Measures associated with sleep | Changes in actigraphy watch measured sleep efficiency (ratio of time spent asleep to the time spent in bed) in percentage from week 0 (baseline) to week 12 (end of study). | Week 0 and 12 | 
| Nitrogen balance | Changes in urinary nitrogen balance (grams per day) from week 0 (baseline) to week 12 (end of study). | Week 0 and 12 | 
| Free insulin-like growth factor 1 | Changes in plasma free insulin-like growth factor 1 concentration (nanogram per deciliter) from week 0 (baseline) to week 12 (end of study). | Week 0 and 12 | 
| Mood | Changes in the Profile of Mood State rating scale categories of tension, depression, anger, fatigue, confusion, vigor, and total mood disturbance from week 0 (baseline) to week 12 (end of study) via a 1 to 5 scale (higher score indicates stronger feeling). | Week 0 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Hypertrophy, Strength, Power