NCT01749189

Brief Summary

This study will investigate the effects of a soy/dairy protein blend on muscle growth and strength. In sports nutrition and in aging it is important to have healthy muscles. This can be achieved with exercise and nutrition. Consumption of protein following resistance exercise can promote healthy muscle growth and help improve strength. Young healthy men will be studied during a 12 week resistance exercise training program and be given protein supplements every day during the study. The hypothesis is that a blend of soy, whey and casein will induce a greater muscle gain and strength increase than the control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

November 15, 2012

Last Update Submit

October 3, 2019

Conditions

Muscle

Keywords

soywheycaseinmusclestrengthprotein

Outcome Measures

Primary Outcomes (1)

  • Change in Muscle Mass

    Muscle Mass will be determined by DEXA

    Baseline, 6 weeks, 12 weeks

Secondary Outcomes (1)

  • Change in Muscle Strength

    Baseline, 6 weeks, 12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo dry blended beverage (carbohydrate)

Dietary Supplement: Placebo

Blend

EXPERIMENTAL

A dry blended beverage containing a protein blend of soy, whey and casein

Dietary Supplement: Blend

Whey

ACTIVE COMPARATOR

A dry blended beverage containing Whey protein

Dietary Supplement: Whey

Interventions

BlendDIETARY_SUPPLEMENT

22 grams of protein/day

Blend
WheyDIETARY_SUPPLEMENT

22 grams of protein/day

Whey
PlaceboDIETARY_SUPPLEMENT

22 grams of carbohydrate/day

Placebo

Eligibility Criteria

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

You may qualify if:

  • Stable body weight, healthy, males aged 18-35

You may not qualify if:

  • Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
  • Resistance Training (\>2 weekly sessions of moderate to high intensity) within the past six months
  • Any orthopedic injury that prohibits participation in the exercise training
  • Significant heart, liver, kidney, blood, or respiratory disease
  • Peripheral vascular disease
  • Diabetes mellitus or other untreated endocrine disease
  • Active cancer (all groups) and history of cancer
  • Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
  • Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
  • Alcohol or drug abuse
  • Tobacco use (smoking or chewing)
  • BMI range will be (20-29.9 kg/m2) to exclude for Malnutrition (hypoalbuminemia, and/or hypotransferrinemia) and Obesity
  • Low hemoglobin levels (below normal values)
  • Food allergies (including milk and soy)
  • Individuals on a Vegetarian Diet
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (2)

  • Reidy PT, Fry CS, Igbinigie S, Deer RR, Jennings K, Cope MB, Mukherjea R, Volpi E, Rasmussen BB. Protein Supplementation Does Not Affect Myogenic Adaptations to Resistance Training. Med Sci Sports Exerc. 2017 Jun;49(6):1197-1208. doi: 10.1249/MSS.0000000000001224.

    PMID: 28346813DERIVED

  • Reidy PT, Borack MS, Markofski MM, Dickinson JM, Deer RR, Husaini SH, Walker DK, Igbinigie S, Robertson SM, Cope MB, Mukherjea R, Hall-Porter JM, Jennings K, Volpi E, Rasmussen BB. Protein Supplementation Has Minimal Effects on Muscle Adaptations during Resistance Exercise Training in Young Men: A Double-Blind Randomized Clinical Trial. J Nutr. 2016 Sep;146(9):1660-9. doi: 10.3945/jn.116.231803. Epub 2016 Jul 27.

    PMID: 27466602DERIVED

MeSH Terms

Interventions

Whey

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Blake Rasmussen, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

  • Mark B Cope, PhD

    Solae, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

December 13, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

US(1)