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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01847261
Other study ID # IRB #12-226
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date December 2014

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

During aging there is a tendency for muscle protein synthesis (growth) to become less efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can affect strength and mobility. Protein consumption may be one opportunity to alleviate this problem especially when consumed in appropriate amounts following resistance training. This study is designed to determine if a soy dairy protein blend, shown to be effective in younger adults, will produce beneficial muscle protein synthesis in older healthy adults following resistance exercise.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 55 Years to 70 Years
Eligibility Inclusion Criteria:

55-70 yr olds Stable Body weight

Exclusion Criteria:

1. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)

2. Significant heart, liver, kidney, blood, respiratory disease or thyroid issues

3. Peripheral vascular disease

4. Orthopedic injury that prohibits participation in the exercise training

5. Diabetes mellitus or other untreated endocrine disease

6. Active cancer (all groups) and history of cancer

7. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)

8. Neurologic Injury or disease

9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.

10. Alcohol or drug abuse

11. Tobacco use (smoking or chewing)

12. Malnutrition (BMI < 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)

13. Obesity (BMI > 30 kg/m2)

14. Low hemoglobin levels (below normal values)

15. Food allergies

16. Taking dietary supplements such as green tea, omega 3 fatty acids, etc.

17. Females

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Soy Dairy Protein Blend

Positive Control (Dairy Whey Protein)


Locations

Country Name City State
United States University of Texas Medical Branch Galveston Texas

Sponsors (1)

Lead Sponsor Collaborator
DuPont Nutrition and Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional Synthetic Rate (Muscle Protein Synthesis) 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 hrs, 5 hrs
Secondary Anti-inflammatory and Anti-oxidant Markers Proteins will be assessed that are markers of oxidative damage and inflammation (NFkB, IL-1, IL-6) and proteolysis (MuRF, MAFBx). baseline, 3 hrs, 5 hrs
Secondary Intracellular Signalling Genes and Proteins Phosphorylation of Mammalian Target of Rapamycin (mTOR) pathway will be measured using Western blot techniques baseline, 3 hrs, 5 hrs
See also
  Status Clinical Trial Phase
Completed NCT01317511 - Protein Supply in Elderly N/A
Completed NCT01358305 - Protein Blends (Soy, Whey and Casein) for Muscle Synthesis N/A