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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
  Purpose

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.


Condition Intervention
Muscle
 Dietary Supplement: Blend
Dietary Supplement: Whey
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Controlled Double Blind Longitudinal Study: Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solae, LLC:

Primary Outcome Measures:
  • Change in Muscle Mass [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Muscle Mass will be determined by DEXA


Secondary Outcome Measures:
  • Change in Muscle Strength [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Knee Extensor


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo dry blended beverage (carbohydrate)
 Dietary Supplement: Placebo
22 grams of carbohydrate/day
Experimental: Blend
A dry blended beverage containing a protein blend of soy, whey and casein
 Dietary Supplement: Blend
22 grams of protein/day
Active Comparator: Whey
A dry blended beverage containing Whey protein
 Dietary Supplement: Whey
22 grams of protein/day

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
  2. Resistance Training (>2 weekly sessions of moderate to high intensity) within the past six months
  3. Any orthopedic injury that prohibits participation in the exercise training
  4. Significant heart, liver, kidney, blood, or respiratory disease
  5. Peripheral vascular disease
  6. Diabetes mellitus or other untreated endocrine disease
  7. Active cancer (all groups) and history of cancer
  8. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
  9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
  10. Alcohol or drug abuse
  11. Tobacco use (smoking or chewing)
  12. BMI range will be (20-29.9 kg/m2) to exclude for Malnutrition (hypoalbuminemia, and/or hypotransferrinemia) and Obesity
  13. Low hemoglobin levels (below normal values)
  14. Food allergies (including milk and soy)
  15. Individuals on a Vegetarian Diet
  16. Females
  17. Average protein intake < 0.6 or >1.8 g/kg per day
  18. Taking dietary supplements such as green tea, creatine, ribose, whey or soy protein, etc. within the past 6 months
  19. Currently on a high-soy diet or high dairy diet (consuming >2 servings of soy per day or >6 servings of dairy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749189

Contacts
Contact: Blake Rasmussen, PhD 4097471619 blrasmus@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Blake Rasmussen, PhD     409-747-1619     blrasmus@utmb.edu    
Principal Investigator: Blake Rasmussen, PhD            
Sponsors and Collaborators
Solae, LLC
Investigators
Principal Investigator: Blake Rasmussen, PhD University of Texas
Principal Investigator: Mark B Cope, PhD Solae, LLC
  More Information

No publications provided

Responsible Party: Solae, LLC
ClinicalTrials.gov Identifier: NCT01749189     History of Changes
Other Study ID Numbers: CRC-D-179
Study First Received: November 15, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Solae, LLC:
soy
whey
casein
 muscle
strength
protein

ClinicalTrials.gov processed this record on May 23, 2013