- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01358305
Protein Blends (Soy, Whey and Casein) for Muscle Synthesis
October 3, 2019 updated by: DuPont Nutrition and Health
A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Galveston, Texas, United States, 77555
- UTMB General Clinical Research Center, located in the John Sealy Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- Age 18-35 yrs
- Stable body weight for at least 1 year
Exclusion criteria will be:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Whey Protein Isolate
|
Single intake of approximately 20 grams of total protein
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Experimental: Protein Blend (soy, whey and casein)
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Single intake of approximately 20 grams of total protein
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Protein Synthesis or Fractional synthesis rate (FSR)
Time Frame: baseline, 3 hours, 5 hours
|
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.
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baseline, 3 hours, 5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oxidative and inflammatory markers
Time Frame: baseline, 3 hours, 5 hours
|
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
|
Phosphorylation of protein in muscle protein signaling pathways
Time Frame: baseline, 3 hours, 5 hours
|
Phosphorylation of mTOR, 4E-BP1, S6K1, S6, and eEF2 will be measured using Western blot techniques as previously described.
|
baseline, 3 hours, 5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ratna Mukherjea, PhD, Solae, LLC
- Principal Investigator: Mark B Cope, PhD, Solae, LLC
- Principal Investigator: Blake B Rasmussen, PhD, UTMB
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
May 19, 2011
First Submitted That Met QC Criteria
May 20, 2011
First Posted (Estimate)
May 23, 2011
Study Record Updates
Last Update Posted (Actual)
October 7, 2019
Last Update Submitted That Met QC Criteria
October 3, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CRC-D-176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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