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CompletedNCT01847261Updated Oct 7, 2019

Effects of Protein Blends on Muscle Protein Synthesis in Healthy Older Adults

An interventional study of Soy Dairy Protein Blend and Positive Control (Dairy Whey Protein) in Muscle Synthesis, sponsored by DuPont Nutrition and Health. Completed at 1 site in United States. Open to male participants aged 55 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-07.

Sponsored by DuPont Nutrition and Health · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
55 Years to 70 Years
Sex
Male
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Study 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.

02

Conditions studied

  • Muscle Synthesis

Keywords

  • soy
  • whey
  • muscle
  • older
  • mTOR
  • sarcopenia
03

In context

Lead sponsor

DuPont Nutrition and Health is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

55-70 yr olds Stable Body weight

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Soy Dairy Protein Blend

    30 grams of Soy Dairy Protein Blend given as a single beverage following leg resistance exercise

    Dietary Supplement: Soy Dairy Protein Blend

  • Active comparator
    Positive Control (Dairy Whey Protein)

    30 grams of Dairy Whey Protein will be given as a single beverage following leg resistance exercise

    Dietary Supplement: Positive Control (Dairy Whey Protein)

Interventions

  • Dietary supplementSoy Dairy Protein Blend
  • Dietary supplementPositive Control (Dairy Whey Protein)
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 3 hrs, 5 hrs

Secondary outcomes

  1. 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).

    Time frame: baseline, 3 hrs, 5 hrs

  2. Intracellular Signalling Genes and Proteins

    Phosphorylation of Mammalian Target of Rapamycin (mTOR) pathway will be measured using Western blot techniques

    Time frame: baseline, 3 hrs, 5 hrs

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Study locations

1 site
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
08

References and documents

Publications

  • Borack MS, Reidy PT, Husaini SH, Markofski MM, Deer RR, Richison AB, Lambert BS, Cope MB, Mukherjea R, Jennings K, Volpi E, Rasmussen BB. Soy-Dairy Protein Blend or Whey Protein Isolate Ingestion Induces Similar Postexercise Muscle Mechanistic Target of Rapamycin Complex 1 Signaling and Protein Synthesis Responses in Older Men. J Nutr. 2016 Dec;146(12):2468-2475. doi: 10.3945/jn.116.231159. Epub 2016 Oct 26. PubMed 27798330 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01847261
Lead sponsor
DuPont Nutrition and Health
Responsible party
Sponsor
First posted
May 6, 2013
Start date
Apr 2013
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Oct 7, 2019

Study contacts

Blake Rasmussen, PhD
principal investigator · University of Texas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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