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CompletedNCT01358305Updated Oct 7, 2019

Protein Blends (Soy, Whey and Casein) for Muscle Synthesis

An interventional study of Protein Blend in Muscle Synthesis, sponsored by DuPont Nutrition and Health. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-07.

Sponsored by DuPont Nutrition and Health · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Muscle Synthesis

Keywords

  • muscle
  • synthesis
  • mTOR
  • antioxidant
  • inflammatory markers
  • soy protein
  • whey
  • casein
03

In context

Lead sponsor

DuPont Nutrition and Health is the lead sponsor of 6 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
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    Whey Protein Isolate

    Other: Protein Blend

  • Experimental
    Protein Blend (soy, whey and casein)

    Other: Protein Blend

Interventions

  • OtherProtein Blend

    Single intake of approximately 20 grams of total protein

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 3 hours, 5 hours

Secondary outcomes

  1. 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).

    Time frame: baseline, 3 hours, 5 hours

  2. 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.

    Time frame: baseline, 3 hours, 5 hours

07

Study locations

1 site
  • UTMB General Clinical Research Center, located in the John Sealy Hospital
    Galveston, Texas 77555, United States
08

References and documents

Publications

  • 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. PubMed 23343671 ↗
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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 ↗
10

Registry details

Key details

Study ID
NCT01358305
Lead sponsor
DuPont Nutrition and Health
Collaborators
University of Texas
Responsible party
Sponsor
First posted
May 23, 2011
Start date
Jan 2011
Primary completion
Aug 2012
Completion
Mar 2013
Last update
Oct 7, 2019

Study contacts

Ratna Mukherjea, PhD
principal investigator · Solae, LLC
Mark B Cope, PhD
principal investigator · Solae, LLC
Blake B Rasmussen, PhD
principal investigator · UTMB

Oversight

Data monitoring committee
Yes
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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