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Resistance Training and Milk Supplementation

Primary Purpose

Muscular Hypertrophy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

high protein milk

Placebo

About this trial

This is an interventional basic science trial for Muscular Hypertrophy focused on measuring Hypertrophy, body composition, milk, resistance training

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Aged 18-35 years of age
Healthy Males
Experienced at resistance training (at least 1 year of prior structured resistance training 3 x week).

Exclusion Criteria:

smoking
chronic alcohol consumption
having any medical issues and diseases
lactose intolerance
the consumption of any dietary supplements (including vitamins or protein supplements) or medications for 6 months prior to participation

Sites / Locations

Marymount University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High protein milk

Placebo

Arm Description

Experimental: High protein milk consumption This arm involved High protein milk whole consumption concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.

This arm involved consumption of a maltodextrin drink with a 9% solution with a vanilla flavor concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime. drink r

Outcomes

Primary Outcome Measures

Circulatory Myokines levels

Fasting blood samples were collected from the antecubital vein using standard procedures and then analyzed to establish concentration of myostatin and follistatin.

Circulatory hormone levels

Fasting blood samples were collected from the antecubital vein using standard procedures and then analyzed to establish concentrations of testosterone, IGF-1, growth hormone, insulin and cortisol

Body composition

Lean body mass and body fatness will be evaluated using bioelectrical impedance

Secondary Outcome Measures

Muscular Strength

Using a 1 repetition maximum test (defined as the maximal weight an individual can lift for only one repetition) for the bench press and back squat exercises

Muscular Power

Using the Wingate test

Full Information

NCT ID

NCT04509297

First Posted

August 5, 2020

Last Updated

August 10, 2020

Sponsor

Marymount University

Collaborators

University of Tehran

1. Study Identification

Unique Protocol Identification Number

NCT04509297

Brief Title

Resistance Training and Milk Supplementation

Official Title

Effects of High-protein Milk Supplementation on Muscular Strength and Power, Body Composition, and Skeletal Muscle Regulatory Markers Following Heavy Resistance Training in Resistance-trained Men

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

January 4, 2018 (Actual)

Primary Completion Date

May 5, 2018 (Actual)

Study Completion Date

May 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marymount University

Collaborators

University of Tehran

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

Post-resistance training high protein milk supplementation may be a viable method to elicit muscular gains. The investigators hypothesis is that high protein milk supplementation would improve skeletal regulatory markers, hormonal responses and body composition in resistance-trained men.

Detailed Description

The aim of this investigation was to compare the effects of high protein milk supplementation (daily and after training sessions) during 6 weeks of resistance training on skeletal muscle regulatory markers, hormonal responses and body composition in resistance-trained men. Specific aims of the study are to: To investigate the extent to which high protein milk supplementation will improve anabolic factors, lean body mass, fat mass and decrease catabolic markers after 6 weeks of resistance training in resistance-trained men.

6. Conditions and Keywords

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

Muscular Hypertrophy

Keywords

Hypertrophy, body composition, milk, resistance training

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High protein milk

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

high protein milk

Intervention Description

This intervention consisted of high protein milk consumption concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

This intervention consisted of the consumption of a maltodextrin drink with a 9% solution with a vanilla flavor concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.

Primary Outcome Measure Information:

Title

Circulatory Myokines levels

Description

Fasting blood samples were collected from the antecubital vein using standard procedures and then analyzed to establish concentration of myostatin and follistatin.

Time Frame

6 weeks

Title

Circulatory hormone levels

Description

Fasting blood samples were collected from the antecubital vein using standard procedures and then analyzed to establish concentrations of testosterone, IGF-1, growth hormone, insulin and cortisol

Time Frame

6 weeks

Title

Body composition

Description

Lean body mass and body fatness will be evaluated using bioelectrical impedance

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Muscular Strength

Description

Using a 1 repetition maximum test (defined as the maximal weight an individual can lift for only one repetition) for the bench press and back squat exercises

Time Frame

6 weeks

Title

Muscular Power

Description

Using the Wingate test

Time Frame

6 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: Aged 18-35 years of age Healthy Males Experienced at resistance training (at least 1 year of prior structured resistance training 3 x week). Exclusion Criteria: smoking chronic alcohol consumption having any medical issues and diseases lactose intolerance the consumption of any dietary supplements (including vitamins or protein supplements) or medications for 6 months prior to participation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexei Wong

Organizational Affiliation

Marymount University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marymount University

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22207

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Resistance Training and Milk Supplementation

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