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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01358305
Other study ID # CRC-D-176
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date March 2013

Study information

Verified date October 2019
Source DuPont Nutrition and Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date March 2013
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Protein Blend
Single intake of approximately 20 grams of total protein

Locations

Country Name City State
United States UTMB General Clinical Research Center, located in the John Sealy Hospital Galveston Texas

Sponsors (2)

Lead Sponsor Collaborator
DuPont Nutrition and Health University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Protein Synthesis or Fractional synthesis rate (FSR) The fractional synthesis rate (FSR) of mixed muscle proteins will be calculated from the incorporation rate of L-[ring-13C6]Phenylalanine into the mixed muscle proteins, and the free-tissue phenylalanine enrichment. baseline, 3 hours, 5 hours
Secondary oxidative and inflammatory markers Proteins will be assessed that are markers of oxidative damage and inflammation (NFkB, IL-1, IL-6) and proteolysis (MuRF, MAFBx). baseline, 3 hours, 5 hours
Secondary Phosphorylation of protein in muscle protein signaling pathways Phosphorylation of mTOR, 4E-BP1, S6K1, S6, and eEF2 will be measured using Western blot techniques as previously described. baseline, 3 hours, 5 hours
See also
  Status Clinical Trial Phase
Completed NCT01317511 - Protein Supply in Elderly N/A
Completed NCT01847261 - Effects of Protein Blends on Muscle Protein Synthesis in Healthy Older Adults N/A