Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Solae, LLC
ClinicalTrials.gov Identifier:
NCT01749189
First received: November 15, 2012
Last updated: June 3, 2014
Last verified: June 2014

November 15, 2012
June 3, 2014
July 2012
May 2014   (final data collection date for primary outcome measure)
Change in Muscle Mass [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
Muscle Mass will be determined by DEXA
Same as current
Complete list of historical versions of study NCT01749189 on ClinicalTrials.gov Archive Site
Change in Muscle Strength [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
Knee Extensor
Same as current
Not Provided
Not Provided
 
Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength
A Randomized, Controlled Double Blind Longitudinal Study: Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Muscle
  • Dietary Supplement: Blend
    22 grams of protein/day
  • Dietary Supplement: Whey
    22 grams of protein/day
  • Dietary Supplement: Placebo
    22 grams of carbohydrate/day
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2015
May 2014   (final data collection date for primary outcome measure)

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)
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01749189
CRC-D-179
No
Solae, LLC
Solae, LLC
Not Provided
Principal Investigator: Blake Rasmussen, PhD University of Texas
Principal Investigator: Mark B Cope, PhD Solae, LLC
Solae, LLC
June 2014

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