Clinical trial NCT01358305: Protein Blends (Soy, Whey and Casein) for Muscle Synthesis
Official title: A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Synthesis
Keywords: muscle
synthesis
mTOR
antioxidant
inflammatory markers
soy protein
whey
casein
Lead sponsor: DuPont Nutrition and Health
Sponsor class: INDUSTRY
Collaborators: name: University of Texas
First posted: 2011-05-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Soy protein is a high quality, plant-based protein that is comparable to milk, meat and eggs. Soy protein has a digestion rate (intermediate) compared to whey (fast) and casein (slow). This intermediate rate may allow soy protein to have an extended window of muscle protein synthesis that has not been monitored in previous studies. While most of the sports nutrition "recovery" products are dairy-based protein blends (high in branched-chain amino acids), soy protein offers additional benefits that can make an important contribution to these types of sports nutrition products. Soy protein contains approximately 300% more arginine and 30% more glutamine compared to whey protein and these two amino acids may bring additional benefits (immunity and hydration, respectively) to athletes. A "blend" of high-quality proteins (soy and dairy) may be the optimal sports nutrition product for athletes to consume following training.


Eligibility criteria: Inclusion:

1. Age 18-35 yrs
2. Stable body weight for at least 1 year

Exclusion criteria will be:

1. Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
2. Significant heart, liver, kidney, blood, or respiratory disease
3. Peripheral vascular disease
4. Diabetes mellitus or other untreated endocrine disease
5. Active cancer (all groups) and history of cancer (groups potentially randomizable to rapamycin)
6. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
7. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
8. Alcohol or drug abuse
9. Tobacco use (smoking or chewing)
10. Malnutrition (BMI \< 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)
11. Obesity (BMI \> 30 kg/m2)
12. Low hemoglobin levels (below normal values)
13. Food allergies
14. Taking dietary supplements such as green tea, etc.
15. Currently on a high-soy diet (consuming \>2 servings of soy per day)

Primary outcomes:
measure: Muscle Protein Synthesis or Fractional synthesis rate (FSR)
timeFrame: baseline, 3 hours, 5 hours
Secondary outcomes:
measure: oxidative and inflammatory markers
timeFrame: baseline, 3 hours, 5 hours
measure: Phosphorylation of protein in muscle protein signaling pathways
timeFrame: baseline, 3 hours, 5 hours
Other outcomes:
Locations:
city: Galveston
country: United States
facility: UTMB General Clinical Research Center, located in the John Sealy Hospital
state: Texas
Study officials:
affiliation: Solae, LLC
name: Ratna Mukherjea, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Solae, LLC
name: Mark B Cope, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UTMB
name: Blake B Rasmussen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reidy PT, Walker DK, Dickinson JM, Gundermann DM, Drummond MJ, Timmerman KL, Fry CS, Borack MS, Cope MB, Mukherjea R, Jennings K, Volpi E, Rasmussen BB. Protein blend ingestion following resistance exercise promotes human muscle protein synthesis. J Nutr. 2013 Apr;143(4):410-6. doi: 10.3945/jn.112.168021. Epub 2013 Jan 23.