Muscle SynthesisNCT01358305
Protein Blends (Soy, Whey and Casein) for Muscle Synthesis
A study testing Protein Blend in people with Muscle Synthesis, run by DuPont Nutrition and Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Synthesis
- What is being tested?
- Protein Blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35 yrs
- Stable body weight for at least 1 year
Who cannot join
- 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)
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UTMB General Clinical Research Center, located in the John Sealy Hospital
Galveston, Texas, 77555
About this study
Official title: 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.
- Conditions
- Muscle Synthesis
- Being tested
- Protein Blend
- Keywords
- muscle, synthesis, mTOR, antioxidant, inflammatory markers, soy protein, whey, casein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein BlendOther
Single intake of approximately 20 grams of total protein
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein Isolate | Active comparator | Not described Receives: Other: Protein Blend |
| Protein Blend (soy, whey and casein) | Experimental | Not described Receives: Other: Protein Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 hours, 5 hours
Secondary outcomes (2)
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).
Measured: baseline, 3 hours, 5 hours
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.
Measured: baseline, 3 hours, 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SynthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- DuPont Nutrition and Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Ratna Mukherjea, PhD, Principal investigator, Solae, LLCMark B Cope, PhD, Principal investigator, Solae, LLCBlake B Rasmussen, PhD, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358305
- Sponsor's protocol ID
- CRC-D-176
- Status last verified
- Oct 2019
- First submitted
- 19 May 2011
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown
- ClinicalTrials.gov ID
- NCT01358305
- Acronym / sponsor ID
- CRC-D-176
- Conditions
- Muscle Synthesis
- Keywords
- muscle, synthesis, mTOR, antioxidant, inflammatory markers, soy protein, whey, casein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- DuPont Nutrition and HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey Protein Isolate | Active comparator | Other: Protein Blend |
| Protein Blend (soy, whey and casein) | Experimental | Other: Protein Blend |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-35 yrs
- Stable body weight for at least 1 year
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein BlendSingle intake of approximately 20 grams of total protein | Other | Protein Blend (soy, whey and casein), Whey Protein Isolate |
Primary outcome
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.
2 secondary outcomes
oxidative and inflammatory markers
Time frame: baseline, 3 hours, 5 hours
Phosphorylation of protein in muscle protein signaling pathways
Time frame: baseline, 3 hours, 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Derived from this study: PubMed 23343671Reidy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratna Mukherjea, PhD principal investigator
Solae, LLC
Mark B Cope, PhD principal investigator
Solae, LLC
Blake B Rasmussen, PhD principal investigator
UTMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Blend in people with Muscle Synthesis, run by DuPont Nutrition and Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Protein Synthesis or Fractional synthesis rate (FSR) (time frame: baseline, 3 hours, 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01358305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.