AgingNCT05922475
Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training
A study testing Protein in people with Aging, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2017to 3 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male between 60-75 years old at the time of enrollment.
Who cannot join
- Diagnosis of cardiac or peripheral vascular disease
- Stroke, kidney dysfunction
- Metabolic disease
- Uncontrolled hypertension
- Orthopedic limitations
- Skeletal muscle complications
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: 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?
Read more
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
- Being tested
- Protein, Placebo
- Keywords
- Exercise, Hypertrophy, Strength, Power
- Medical subject headings
- Motor Activity, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Post-exercise protein group consumed protein immediately after exercise sessions.
Pre-sleep protein group consumed protein 30 minutes before sleep.
PlaceboOther
Resistance exercise training only group did not consume supplemental protein.
| Study group | Role | What they receive |
|---|---|---|
| Post-exercise protein | Experimental | Consumed 40 g of supplemental protein immediately after exercise sessions and in between breakfast and lunch on non-exercise days. Receives: Dietary Supplement: Protein |
| Pre-sleep protein | Experimental | Consumed 40 g of supplemental protein 30 minutes before sleep every day. Receives: Dietary Supplement: Protein |
| Resistance exercise training only | Placebo comparator | Did not consume supplemental protein. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 0, 6, and 12
Secondary outcomes (10)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 0 and 12
Nitrogen balance
Changes in urinary nitrogen balance (grams per day) from week 0 (baseline) to week 12 (end of study).
Measured: 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).
Measured: 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).
Measured: Week 0 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start27 Sep 2017
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Klemp, Florida State University
- Investigators
- Alex O Klemp, PhD, Principal investigator, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922475
- Sponsor's protocol ID
- 25996
- Status last verified
- Jun 2023
- First submitted
- 27 May 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40539259
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neither Pre-sleep Nor Post-exercise Protein Consumption Influences Resistance Exercise Training Adaptations in Older Adults
- ClinicalTrials.gov ID
- NCT05922475
- Acronym / sponsor ID
- 25996
- Conditions
- Aging
- Keywords
- Exercise, Hypertrophy, Strength, Power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-exercise protein | Experimental | Dietary Supplement: ProteinConsumed 40 g of supplemental protein immediately after exercise sessions and in between breakfast and lunch on non-exercise days. |
| Pre-sleep protein | Experimental | Dietary Supplement: ProteinConsumed 40 g of supplemental protein 30 minutes before sleep every day. |
| Resistance exercise training only | Placebo comparator | Other: PlaceboDid not consume supplemental protein. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male between 60-75 years old at the time of enrollment.
Key exclusion criteria (13 listed)
- Diagnosis of cardiac or peripheral vascular disease
- Stroke, kidney dysfunction
- Metabolic disease
- Uncontrolled hypertension
- Orthopedic limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProteinPost-exercise protein group consumed protein immediately after exercise sessions. Pre-sleep protein group consumed protein 30 minutes before sleep. | Dietary supplement | Post-exercise protein, Pre-sleep protein |
| PlaceboResistance exercise training only group did not consume supplemental protein. | Other | Resistance exercise training only |
Primary outcome
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).
10 secondary outcomes
Maximum muscular strength
Time frame: Week 0, 6, and 12
Muscle power
Time frame: Week 0, 6, and 12
Cognitive performance
Time frame: Week 0 and 12
Measures associated appetite
Time frame: Week 0, 6, and 12
Total sleep time
Time frame: Week 0 and 12
Sleep latency
Time frame: Week 0 and 12
Measures associated with sleep
Time frame: Week 0 and 12
Nitrogen balance
Time frame: Week 0 and 12
Free insulin-like growth factor 1
Time frame: Week 0 and 12
Mood
Time frame: Week 0 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 40539259Klemp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex O Klemp, PhD principal investigator
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein in people with Aging, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle thickness (time frame: Week 0, 6, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.