Muscle SynthesisNCT01847261
Effects of Protein Blends on Muscle Protein Synthesis in Healthy Older Adults
A study testing Soy Dairy Protein Blend in people with Muscle Synthesis, run by DuPont Nutrition and Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Synthesis
- What is being tested?
- Soy Dairy Protein Blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2014
- 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 55 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55-70 yr olds Stable Body weight
Who cannot join
- Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
- Significant heart, liver, kidney, blood, respiratory disease or thyroid issues
- Peripheral vascular disease
- Orthopedic injury that prohibits participation in the exercise training
- Diabetes mellitus or other untreated endocrine disease
- Active cancer (all groups) and history of cancer
Show all 17Show fewer
- Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
- Neurologic Injury or disease
- 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, omega 3 fatty acids, etc.
- Females
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
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 in Healthy Older Adults
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.
- Conditions
- Muscle Synthesis
- Being tested
- Soy Dairy Protein Blend, Positive Control (Dairy Whey Protein)
- Keywords
- soy, whey, muscle, older, mTOR, sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy Dairy Protein BlendDietary supplement
Positive Control (Dairy Whey Protein)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Soy Dairy Protein Blend | Experimental | 30 grams of Soy Dairy Protein Blend given as a single beverage following leg resistance exercise Receives: Dietary Supplement: Soy Dairy Protein Blend |
| Positive Control (Dairy Whey Protein) | Active comparator | 30 grams of Dairy Whey Protein will be given as a single beverage following leg resistance exercise Receives: Dietary Supplement: Positive Control (Dairy Whey Protein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 hrs, 5 hrs
Secondary outcomes (2)
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).
Measured: baseline, 3 hrs, 5 hrs
Intracellular Signalling Genes and Proteins
Phosphorylation of Mammalian Target of Rapamycin (mTOR) pathway will be measured using Western blot techniques
Measured: baseline, 3 hrs, 5 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionDec 2014
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DuPont Nutrition and Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Blake Rasmussen, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847261
- Sponsor's protocol ID
- IRB #12-226
- Status last verified
- Oct 2019
- First submitted
- 24 Apr 2013
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
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
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 in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT01847261
- Acronym / sponsor ID
- IRB #12-226
- Conditions
- Muscle Synthesis
- Keywords
- soy, whey, muscle, older, mTOR, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DuPont Nutrition and HealthIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 May 2013 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy Dairy Protein Blend | Experimental | Dietary Supplement: Soy Dairy Protein Blend30 grams of Soy Dairy Protein Blend given as a single beverage following leg resistance exercise |
| Positive Control (Dairy Whey Protein) | Active comparator | Dietary Supplement: Positive Control (Dairy Whey Protein)30 grams of Dairy Whey Protein will be given as a single beverage following leg resistance exercise |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 55-70 yr olds Stable Body weight
Key exclusion criteria (17 listed)
- Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
- Significant heart, liver, kidney, blood, respiratory disease or thyroid issues
- Peripheral vascular disease
- Orthopedic injury that prohibits participation in the exercise training
- Diabetes mellitus or other untreated endocrine disease
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 |
|---|---|---|
| Soy Dairy Protein Blend | Dietary supplement | Soy Dairy Protein Blend |
| Positive Control (Dairy Whey Protein) | Dietary supplement | Positive Control (Dairy Whey Protein) |
Primary outcome
Fractional Synthetic Rate (Muscle Protein Synthesis)
Time frame: baseline, 3 hrs, 5 hrs
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
Anti-inflammatory and Anti-oxidant Markers
Time frame: baseline, 3 hrs, 5 hrs
Intracellular Signalling Genes and Proteins
Time frame: baseline, 3 hrs, 5 hrs
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 27798330Borack 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.
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Acute Effects of Ketone Monoester Co-Ingestion With Dietary Protein on Whole-Body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Older Males
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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.
Blake Rasmussen, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy Dairy 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 1 inclusion and 17 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?
Fractional Synthetic Rate (Muscle Protein Synthesis) (time frame: baseline, 3 hrs, 5 hrs). 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 NCT01847261, 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.