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

Sponsor
Florida State University (Other)
Overall Status
Completed
CT.gov ID
NCT05922475
Collaborator
(none)
32
1
3
19.2
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Protein
  • Other: Placebo
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Neither Pre-sleep Nor Post-exercise Protein Consumption Influences Resistance Exercise Training Adaptations in Older Adults
Actual Study Start Date :
Sep 27, 2017
Actual Primary Completion Date :
May 3, 2019
Actual Study Completion Date :
May 3, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Muscle thickness [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 Outcome Measures

  1. Maximum muscular strength [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 [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 [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 [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 [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 [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 [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida State University Tallahassee Florida United States 32306

Sponsors and Collaborators

  • Florida State University

Investigators

  • Principal Investigator: Alex O Klemp, PhD, Student

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Alexander Klemp, Principal investigator, Florida State University
ClinicalTrials.gov Identifier:
NCT05922475
Other Study ID Numbers:
  • 25996
First Posted:
Jun 28, 2023
Last Update Posted:
Jun 28, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexander Klemp, Principal investigator, Florida State University

Study Results

No Results Posted as of Jun 28, 2023