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

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ClinicalTrials.gov Identifier: NCT01749189
Recruitment Status : Unknown
Verified June 2014 by Solae, LLC.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2012
Last Update Posted : June 5, 2014
Information provided by (Responsible Party):
Solae, LLC

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.

Condition or disease Intervention/treatment
Muscle Dietary Supplement: Blend Dietary Supplement: Whey Dietary Supplement: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2012
Primary Completion Date : May 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Muscle Mass [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Muscle Mass will be determined by DEXA

Secondary Outcome Measures :
  1. Change in Muscle Strength [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Knee Extensor

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749189

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Solae, LLC
Principal Investigator: Blake Rasmussen, PhD University of Texas
Principal Investigator: Mark B Cope, PhD Solae, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Solae, LLC
ClinicalTrials.gov Identifier: NCT01749189     History of Changes
Other Study ID Numbers: CRC-D-179
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014

Keywords provided by Solae, LLC: