NCT04509297

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 4, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 5, 2020

Last Update Submit

August 10, 2020

Conditions

Muscular Hypertrophy

Keywords

Hypertrophybody compositionmilkresistance training

Outcome Measures

Primary Outcomes (3)

  • 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.

    6 weeks

  • 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

    6 weeks

  • Body composition

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

    6 weeks

Secondary Outcomes (2)

  • Muscular Strength

    6 weeks

  • Muscular Power

    6 weeks

Study Arms (2)

High protein milk

EXPERIMENTAL

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.

Dietary Supplement: high protein milkDietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: high protein milkDietary Supplement: Placebo

Interventions

high protein milkDIETARY_SUPPLEMENT

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.

High protein milkPlacebo
PlaceboDIETARY_SUPPLEMENT

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.

High protein milkPlacebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marymount University

Arlington, Virginia, 22207, United States

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alexei Wong

    Marymount University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 12, 2020

Study Start

January 4, 2018

Primary Completion

May 5, 2018

Study Completion

May 5, 2018

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)