Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength

This study is currently recruiting participants.

Verified December 2012 by Solae, LLC

Sponsor:

Information provided by (Responsible Party):

Solae, LLC

ClinicalTrials.gov Identifier:

NCT01749189

First received: November 15, 2012

Last updated: December 12, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 15, 2012

Last Updated Date

December 12, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Muscle Mass [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Muscle Mass will be determined by DEXA

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01749189 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Muscle Strength [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Knee Extensor

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength

Official Title ^ICMJE

A Randomized, Controlled Double Blind Longitudinal Study: Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Condition ^ICMJE

Muscle

Intervention ^ICMJE

Dietary Supplement: Blend
22 grams of protein/day
Dietary Supplement: Whey
22 grams of protein/day
Dietary Supplement: Placebo
22 grams of carbohydrate/day

Study Arm (s)

Placebo Comparator: Placebo
Placebo dry blended beverage (carbohydrate)

Intervention: Dietary Supplement: Placebo
Experimental: Blend
A dry blended beverage containing a protein blend of soy, whey and casein

Intervention: Dietary Supplement: Blend
Active Comparator: Whey
A dry blended beverage containing Whey protein

Intervention: Dietary Supplement: Whey

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Stable body weight, healthy, males aged 18-35

Exclusion Criteria:

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
Females
Average protein intake < 0.6 or >1.8 g/kg per day
Taking dietary supplements such as green tea, creatine, ribose, whey or soy protein, etc. within the past 6 months
Currently on a high-soy diet or high dairy diet (consuming >2 servings of soy per day or >6 servings of dairy)

Gender

Male

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Blake Rasmussen, PhD

4097471619

blrasmus@utmb.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01749189

Other Study ID Numbers ^ICMJE

CRC-D-179

Has Data Monitoring Committee

Responsible Party

Solae, LLC

Study Sponsor ^ICMJE

Solae, LLC

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Blake Rasmussen, PhD	University of Texas
Principal Investigator:	Mark B Cope, PhD	Solae, LLC

Information Provided By

Solae, LLC

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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