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

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Protein; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Principal Investigator: Alex O Klemp, PhD, Student

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Actual): May 3, 2019
• Study Completion (Actual): May 3, 2019

Study Registration Dates

• First Submitted: May 27, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Hypertrophy; Strength; Power
• Other Study ID Numbers: 25996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No