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

NCT05922475 | Completed

• 1 other identifier: 25996
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Exercise; Hypertrophy; Strength; Power

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Maximum muscular strength

  Week 0, 6, and 12

• Muscle power

  Week 0, 6, and 12

• Cognitive performance

  Week 0 and 12

• Measures associated appetite

  Week 0, 6, and 12

• Total sleep time

  Week 0 and 12

Study Arms (3)

Post-exercise protein

EXPERIMENTAL

Consumed 40 g of supplemental protein immediately after exercise sessions and in between breakfast and lunch on non-exercise days.

Dietary Supplement: Protein

Pre-sleep protein

EXPERIMENTAL

Consumed 40 g of supplemental protein 30 minutes before sleep every day.

Dietary Supplement: Protein

Resistance exercise training only

PLACEBO COMPARATOR

Did not consume supplemental protein.

Other: Placebo

Interventions

Protein DIETARY_SUPPLEMENT

Post-exercise protein group consumed protein immediately after exercise sessions. Pre-sleep protein group consumed protein 30 minutes before sleep.

Post-exercise protein; Pre-sleep protein

Placebo OTHER

Resistance exercise training only group did not consume supplemental protein.

Resistance exercise training only

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male between 60-75 years old at the time of enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

• Klemp AO, Ormsbee MJ, Yeh M, Sokolowski CM, Kim DH, Panton LB, Kim JS. Neither pre-sleep nor post-exercise protein consumption influences resistance exercise training adaptations in older adults. J Int Soc Sports Nutr. 2025 Dec;22(1):2519511. doi: 10.1080/15502783.2025.2519511. Epub 2025 Jun 20.

  PMID: 40539259 DERIVED

MeSH Terms

Conditions

Motor Activity; Hypertrophy

Interventions

Proteins

Condition Hierarchy (Ancestors)

Behavior; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Alex O Klemp, PhD

  Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 28, 2023
• Study Start: September 27, 2017
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)