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Protein Ingestion Timing on Body Composition and Biochemical Markers in Resistance-trained Males

Primary Purpose

Hypertrophy, Physical Performance

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

isolate whey protein prior to and immediately after resistance training

isolate whey protein 3 hours prior to and 3 hours after resistance training

About this trial

This is an interventional basic science trial for Hypertrophy

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Marymount University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Protein ingestion immediately prior to and immediately after resistance training

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

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Body Composition

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

Secondary Outcome Measures

Muscular Strength

Using 1 repetition maximum

Muscular Endurance

Using leg- and chest press exercises at 75% of the 1-RM

Jump testing

Using the vertical and broad jump tests

Pull-ups

Using the pull-up test

Liver enzymes (ALT, AST, and GGT)

Using Fasting blood samples

Creatinine and Urea Nitrogen

Urine samples will be collected using standard procedures

Cholesterol Levels

Using Fasting blood samples

Full Information

NCT ID

NCT05544955

First Posted

September 12, 2022

Last Updated

September 14, 2022

Sponsor

Marymount University

Collaborators

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05544955

Brief Title

Protein Ingestion Timing on Body Composition and Biochemical Markers in Resistance-trained Males

Official Title

Comparison of Protein Ingestion Timing on Body Composition, Physical Performance, and Biochemical Markers in Resistance-trained Males

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 17, 2022 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marymount University

Collaborators

Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Protein ingestion timing is an important component for muscle accretion. We hypothesized that protein ingestion timing could affect muscular adaptations and performance in resistance-trained men.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrophy, Physical Performance

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Protein ingestion immediately prior to and immediately after resistance training

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

isolate whey protein prior to and immediately after resistance training

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

isolate whey protein 3 hours prior to and 3 hours after resistance training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Body Composition

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Muscular Strength

Description

Using 1 repetition maximum

Time Frame

12 weeks

Title

Muscular Endurance

Description

Using leg- and chest press exercises at 75% of the 1-RM

Time Frame

12 weeks

Title

Jump testing

Description

Using the vertical and broad jump tests

Time Frame

12 weeks

Title

Pull-ups

Description

Using the pull-up test

Time Frame

12 weeks

Title

Liver enzymes (ALT, AST, and GGT)

Description

Using Fasting blood samples

Time Frame

12 weeks

Title

Creatinine and Urea Nitrogen

Description

Urine samples will be collected using standard procedures

Time Frame

12 weeks

Title

Cholesterol Levels

Description

Using Fasting blood samples

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexei Wong

Phone

17039087609

awong@marymount.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Alexei Wong

awong@marymount.edu

Facility Information:

Facility Name

Marymount University

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22207

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexei Wong

Phone

703-908-7609

awong@marymount.edu

12. IPD Sharing Statement

Learn more about this trial

Protein Ingestion Timing on Body Composition and Biochemical Markers in Resistance-trained Males

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