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Completed

NCT Number: NCT05922475

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

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.

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Key information

Conditions

Aging Behavior Hypertrophy Motor Activity Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein

Dietary Supplement

Post-exercise protein group consumed protein immediately after exercise sessions.

Pre-sleep protein group consumed protein 30 minutes before sleep.

Placebo

Other

Resistance exercise training only group did not consume supplemental protein.

Primary outcomes

  1. Muscle thickness

    Time frame: Week 0, 6, and 12

    Change in muscle thickness of the quadriceps muscles in centimeters from week 0 (baseline) to week 6 (midpoint) to week 12 (end of study).

Secondary outcomes

  1. Maximum muscular strength

    Time frame: Week 0, 6, and 12

    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).

  2. Muscle power

    Time frame: Week 0, 6, and 12

    Changes in power (Watts) during a sit-to-stand task from week 0 (baseline) to week 6 (midpoint) to week 12 (end of study).

  3. Cognitive performance

    Time frame: Week 0 and 12

    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).

  4. Measures associated appetite

    Time frame: Week 0, 6, and 12

    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).

  5. Total sleep time

    Time frame: Week 0 and 12

    Changes in actigraphy watch measured total sleep time in hours from week 0 (baseline) to week 12 (end of study).

  6. Sleep latency

    Time frame: Week 0 and 12

    Changes in actigraphy watch measured sleep latency in minutes from week 0 (baseline) to week 12 (end of study).

  7. Measures associated with sleep

    Time frame: Week 0 and 12

    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).

  8. Nitrogen balance

    Time frame: Week 0 and 12

    Changes in urinary nitrogen balance (grams per day) from week 0 (baseline) to week 12 (end of study).

  9. Free insulin-like growth factor 1

    Time frame: Week 0 and 12

    Changes in plasma free insulin-like growth factor 1 concentration (nanogram per deciliter) from week 0 (baseline) to week 12 (end of study).

  10. Mood

    Time frame: Week 0 and 12

    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).

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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