NCT01358305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1.6 years

First QC Date

May 19, 2011

Last Update Submit

October 3, 2019

Conditions

Muscle Synthesis

Keywords

musclesynthesismTORantioxidantinflammatory markerssoy proteinwheycasein

Outcome Measures

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.

    baseline, 3 hours, 5 hours

Secondary Outcomes (2)

  • oxidative and inflammatory markers

    baseline, 3 hours, 5 hours

  • Phosphorylation of protein in muscle protein signaling pathways

    baseline, 3 hours, 5 hours

Study Arms (2)

Whey Protein Isolate

ACTIVE COMPARATOR
Other: Protein Blend

Protein Blend (soy, whey and casein)

EXPERIMENTAL
Other: Protein Blend

Interventions

Protein BlendOTHER

Single intake of approximately 20 grams of total protein

Protein Blend (soy, whey and casein)Whey Protein Isolate

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTMB General Clinical Research Center, located in the John Sealy Hospital

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • 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.

    PMID: 23343671DERIVED

Study Officials

  • Ratna Mukherjea, PhD

    Solae, LLC

    PRINCIPAL INVESTIGATOR

  • Mark B Cope, PhD

    Solae, LLC

    PRINCIPAL INVESTIGATOR

  • Blake B Rasmussen, PhD

    UTMB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2011

First Posted

May 23, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2012

Study Completion

March 1, 2013

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

US(1)