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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05922475
• Other study ID #: 25996
• Status: Completed
• Phase: N/A
• Start date: September 27, 2017
• Est. completion date: May 3, 2019

Study information

• Verified date: June 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Protein
Post-exercise protein group consumed protein immediately after exercise sessions. Pre-sleep protein group consumed protein 30 minutes before sleep.

Other:
• Placebo
Resistance exercise training only group did not consume supplemental protein.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Nitrogen balance	Changes in urinary nitrogen balance (grams per day) from week 0 (baseline) to week 12 (end of study).	Week 0 and 12
Secondary	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
Secondary	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