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

NCT ID: NCT05922475

Last Updated: 2023-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-27

Study Completion Date

2019-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Post-exercise protein

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

Group Type EXPERIMENTAL

Protein

Intervention Type DIETARY_SUPPLEMENT

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

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

Pre-sleep protein

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

Group Type EXPERIMENTAL

Protein

Intervention Type DIETARY_SUPPLEMENT

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

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

Resistance exercise training only

Did not consume supplemental protein.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Resistance exercise training only group did not consume supplemental protein.

Interventions

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Protein

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

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Resistance exercise training only group did not consume supplemental protein.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Alexander Klemp

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alex O Klemp, PhD

Role: PRINCIPAL_INVESTIGATOR

Student

Locations

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Florida State University

Tallahassee, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40539259 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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25996

Identifier Type: -

Identifier Source: org_study_id

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