This trial is active, not recruiting.

Condition muscle
Treatments blend, whey, placebo
Sponsor Solae, LLC
Start date July 2012
End date May 2014
Trial size 60 participants
Trial identifier NCT01749189, CRC-D-179


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
(Placebo Comparator)
Placebo dry blended beverage (carbohydrate)
22 grams of carbohydrate/day
A dry blended beverage containing a protein blend of soy, whey and casein
22 grams of protein/day
(Active Comparator)
A dry blended beverage containing Whey protein
22 grams of protein/day

Primary Outcomes

Change in Muscle Mass
time frame: Baseline, 6 weeks, 12 weeks

Secondary Outcomes

Change in Muscle Strength
time frame: Baseline, 6 weeks, 12 weeks

Eligibility Criteria

Male participants from 18 years up to 35 years old.

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)

Additional Information

Official title A Randomized, Controlled Double Blind Longitudinal Study: Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength
Principal investigator Blake Rasmussen, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Solae, LLC.