Clinical trial NCT01749189: Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength
Official title: A Randomized, Controlled Double Blind Longitudinal Study: Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle
Keywords: soy
whey
casein
muscle
strength
protein
Lead sponsor: DuPont Nutrition and Health
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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)

Primary outcomes:
measure: Change in Muscle Mass
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in Muscle Strength
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Blake Rasmussen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Solae, LLC
name: Mark B Cope, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reidy PT, Fry CS, Igbinigie S, Deer RR, Jennings K, Cope MB, Mukherjea R, Volpi E, Rasmussen BB. Protein Supplementation Does Not Affect Myogenic Adaptations to Resistance Training. Med Sci Sports Exerc. 2017 Jun;49(6):1197-1208. doi: 10.1249/MSS.0000000000001224.
citation: Reidy PT, Borack MS, Markofski MM, Dickinson JM, Deer RR, Husaini SH, Walker DK, Igbinigie S, Robertson SM, Cope MB, Mukherjea R, Hall-Porter JM, Jennings K, Volpi E, Rasmussen BB. Protein Supplementation Has Minimal Effects on Muscle Adaptations during Resistance Exercise Training in Young Men: A Double-Blind Randomized Clinical Trial. J Nutr. 2016 Sep;146(9):1660-9. doi: 10.3945/jn.116.231803. Epub 2016 Jul 27.