NCT05544955

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

September 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

September 12, 2022

Last Update Submit

June 8, 2025

Conditions

HypertrophyPhysical Performance

Outcome Measures

Primary Outcomes (1)

  • Body Composition

    Total Lean mass, fat mass, and estimated VAT (g) will be assessed using whole-body DXA

    12 weeks

Secondary Outcomes (7)

  • Muscular Strength

    12 weeks

  • Muscular Endurance

    12 weeks

  • Jump testing

    12 weeks

  • Pull-ups

    12 weeks

  • Liver enzymes (ALT, AST, and GGT)

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Protein ingestion immediately prior to and immediately after resistance training

EXPERIMENTAL

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.

Dietary Supplement: isolate whey protein prior to and immediately after resistance training

Protein ingestion 3 hours prior to and 3 hours after resistance training

EXPERIMENTAL

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.

Dietary Supplement: isolate whey protein 3 hours prior to and 3 hours after resistance training

Interventions

isolate whey protein prior to and immediately after resistance trainingDIETARY_SUPPLEMENT

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.

Protein ingestion immediately prior to and immediately after resistance training
isolate whey protein 3 hours prior to and 3 hours after resistance trainingDIETARY_SUPPLEMENT

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.

Protein ingestion 3 hours prior to and 3 hours after resistance training

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marymount University

Arlington, Virginia, 22207, United States

Location

MeSH Terms

Conditions

Hypertrophy

Interventions

Lead

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 19, 2022

Study Start

September 17, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 11, 2025

Record last verified: 2025-06

Locations

US(1)