- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05544955
Protein Ingestion Timing on Body Composition and Biochemical Markers in Resistance-trained Males
June 8, 2025 updated by: Alexei Wong, Marymount University
Comparison of Protein Ingestion Timing on Body Composition, Physical Performance, and Biochemical Markers in Resistance-trained Males
Protein ingestion timing is an important component for muscle accretion.
The investigators hypothesized that protein ingestion timing could affect muscular adaptations and performance in resistance-trained men.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Arlington, Virginia, United States, 22207
- Marymount University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- performing resistance training at least three times a week for 1 year prior to the start of the study
- not taking any steroids or any illegal agents known to increase muscle size for at least 1 year prior to the start of the study
- no known medical issues
- sleeping for at least seven to eight hours during the 24-hour day
Exclusion Criteria:
- non-willingness to continue protein ingestion or exercise protocols
- participation in exercise other than the prescribed resistance training program
- consumption of dietary supplement (other than the protein intervention) during the study period
- Missing more than one resistance training session or protein ingestion throughout the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Protein ingestion immediately prior to and immediately after resistance training
This arm involved protein ingestion immediately prior to and immediately after resistance training for 12 weeks.
Participants will consume 40 g of isolate whey protein at their recommended timing.
|
This arm involved protein ingestion immediately prior to and immediately after resistance training for 12 weeks.
Participants will consume 40 g of isolate whey protein at their recommended timing.
|
|
Experimental: Protein ingestion 3 hours prior to and 3 hours after resistance training
This arm involved protein ingestion 3 hours prior to and 3 hours after resistance training for 12 weeks.
Participants will consume 40 g of isolate whey protein at their recommended timing.
|
This arm involved protein ingestion 3 hours prior to and 3 hours after resistance training for 12 weeks.
Participants will consume 40 g of isolate whey protein at their recommended timing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Composition
Time Frame: 12 weeks
|
Total Lean mass, fat mass, and estimated VAT (g) will be assessed using whole-body DXA
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscular Strength
Time Frame: 12 weeks
|
Using 1 repetition maximum
|
12 weeks
|
|
Muscular Endurance
Time Frame: 12 weeks
|
Using leg- and chest press exercises at 75% of the 1-RM
|
12 weeks
|
|
Jump testing
Time Frame: 12 weeks
|
Using the vertical and broad jump tests
|
12 weeks
|
|
Pull-ups
Time Frame: 12 weeks
|
Using the pull-up test
|
12 weeks
|
|
Liver enzymes (ALT, AST, and GGT)
Time Frame: 12 weeks
|
Using Fasting blood samples
|
12 weeks
|
|
Creatinine and Urea Nitrogen
Time Frame: 12 weeks
|
Urine samples will be collected using standard procedures
|
12 weeks
|
|
Cholesterol Levels
Time Frame: 12 weeks
|
Using Fasting blood samples
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
September 12, 2022
First Submitted That Met QC Criteria
September 14, 2022
First Posted (Actual)
September 19, 2022
Study Record Updates
Last Update Posted (Actual)
June 11, 2025
Last Update Submitted That Met QC Criteria
June 8, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.SSRC.REC.1403.059
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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