Regulation of Muscle Protein SynthesisNCT01492010
Role of Leucine in the Regulation of Human Myofibrillar Protein Synthesis at Rest and Following Resistance Exercise
A study testing whey protein, whey protein supplemented with leucine and whey protein supplemented with essential amino acids in people with Regulation of Muscle Protein Synthesis, run by McMaster University at 1 site in Canada.
Trial summary
Muscle mass is normally maintained through the regulated balance between the processes of protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old muscle proteins). Proteins are composed of amino acids and we know that amino acids increase muscle protein synthesis. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Regulation of Muscle Protein Synthesis
- What is being tested?
- whey protein, whey protein supplemented with leucine and whey protein supplemented with essential amino acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Sep 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- 18-35 years of age
- non-smoker/ non-tobacco product user
Who cannot join
- heart disease
- vascular disease
- rheumatoid arthritis
- diabetes
- poor lung function
- uncontrolled blood pressure
- dizziness
- thyroid problems
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Muscle mass is normally maintained through the regulated balance between the processes of protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old muscle proteins). Proteins are composed of amino acids and we know that amino acids increase muscle protein synthesis. However, not all amino acids are the same. Essential amino acids are ones that must be consumed through food, while non-essential amino acids can be made by our body. Interestingly, the essential amino acids are all that are required to increase the rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to be particularly important in regulating protein synthesis. However, how leucine is able to increase protein synthesis is not entirely understood. Previously, it has been shown that 20-25 g of high-quality protein, such as that found in milk, appears to be the amount of protein that maximizes the rate of muscle protein synthesis after performing a bout of resistance exercise. Thus, the aim is to measure the synthesis of new muscle proteins after ingesting the following:
- 25g whey protein
- 6.25g whey protein supplemented with leucine
- 6.25g whey protein supplemented with essential amino acids but no leucine
The investigators will measure muscle protein synthesis after consumption of the above beverages in a leg that has done no exercise ( ie. a rested leg) and in the other leg that has done resistance exercise. The hypothesis is that 6.25g whey supplemented with leucine will stimulate muscle protein synthesis as effectively as 25g whey, but that 6.25g whey supplemented will all the essential amino acids except whey will be less effective at increasing muscle protein synthesis. Whey protein is a dairy-based protein found in cow's milk, thus when you drink a glass of milk you are consuming some whey protein. However, the investigators will be using an isolated form of whey protein, meaning it has been removed from milk. As mentioned previously, amino acids are 'strung-together' to make protein. The 'essential' amino acids must be consumed through food because our body cannot make them, thus they are consumed when you eat protein-rich foods like milk or chicken.
- Conditions
- Regulation of Muscle Protein Synthesis
- Being tested
- whey protein, whey protein supplemented with leucine, whey protein supplemented with essential amino acids
- Keywords
- skeletal muscle, FSR, resistance exercise, leucine, protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey proteinDietary supplement
Also called whey protein powder
25 g whey protein
whey protein supplemented with leucineDietary supplement
Also called whey protein powder supplemented with free-form leucine
6.25 g whey protein supplemented with free form leucine
whey protein supplemented with essential amino acidsDietary supplement
Also called whey protein supplemented with EAA devoid of leucine
6.25 g whey protein supplemented with essential amino acids devoid of leucine
| Study group | Role | What they receive |
|---|---|---|
| 25 g protein | Experimental | 25 g whey protein Receives: Dietary Supplement: whey protein |
| 6.25 g protein supplemented with leucine | Experimental | 6.25 g protein supplemented with leucine Receives: Dietary Supplement: whey protein supplemented with leucine |
| 6.25 g whey protein with EAA | Experimental | 6.25 g protein supplemented with a mixture of essential amino acids devoid of leucine Receives: Dietary Supplement: whey protein supplemented with essential amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound C13phe, by the enrichment of the precursor (= intracellular availability).
Measured: 5 hours postprandial
Secondary outcomes (1)
Signaling molecule phosphorylation status
Western blot will be used to measure the phosphorylation status of signaling molecules involved in protein synthesis ie. mTOR, p70S6k, 4E-BP1.
Measured: 1, 3, and 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionSep 2010
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 Regulation of Muscle Protein SynthesisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart M Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492010
- Sponsor's protocol ID
- LEU-10-141
- Status last verified
- Feb 2020
- First submitted
- 12 Dec 2011
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Churchward-Venne TA, Burd NA, Mitchell CJ, West DW, Philp A, Marcotte GR, Baker SK, Baar K, Phillips SM. Supplementation of a suboptimal protein dose with leucine or essential amino acids: effects on myofibrillar protein synthesis at rest and following resistance exercise in men. J Physiol. 2012 Jun 1;590(11):2751-65. doi: 10.1113/jphysiol.2012.228833. Epub 2012 Mar 25.
PubMed 22451437
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Leucine in the Regulation of Human Myofibrillar Protein Synthesis at Rest and Following Resistance Exercise
- ClinicalTrials.gov ID
- NCT01492010
- Acronym / sponsor ID
- LEU-10-141
- Conditions
- Regulation of Muscle Protein Synthesis
- Keywords
- skeletal muscle, FSR, resistance exercise, leucine, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis, Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council, Canada
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Dec 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.
Muscle mass is normally maintained through the regulated balance between the processes of protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old muscle proteins). Proteins are composed of amino acids and we know that amino acids increase muscle protein synthesis. However, not all amino acids are the same. Essential amino acids are ones that must be consumed through food, while non-essential amino acids can be made by our body. Interestingly, the essential amino acids are all that are required to increase the rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to be particularly important in regulating protein synthesis. However, how leucine is able to increase protein synthesis is not entirely understood. Previously, it has been shown that 20-25 g of high-quality protein, such as that found in milk, appears to be the amount of protein that maximizes the rate of muscle protein synthesis after performing a bout of resistance exercise. Thus, the aim is to measure the synthesis of new muscle proteins after ingesting the following:
- 25g whey protein
- 6.25g whey protein supplemented with leucine
- 6.25g whey protein supplemented with essential amino acids but no leucine
The investigators will measure muscle protein synthesis after consumption of the above beverages in a leg that has done no exercise ( ie. a rested leg) and in the other leg that has done resistance exercise. The hypothesis is that 6.25g whey supplemented with leucine will stimulate muscle protein synthesis as effectively as 25g whey, but that 6.25g whey supplemented will all the essential amino acids except whey will be less effective at increasing muscle protein synthesis. Whey protein is a dairy-based protein found in cow's milk, thus when you drink a glass of milk you are consuming some whey protein. However, the investigators will be using an isolated form of whey protein, meaning it has been removed from milk. As mentioned previously, amino acids are 'strung-together' to make protein. The 'essential' amino acids must be consumed through food because our body cannot make them, thus they are consumed when you eat protein-rich foods like milk or chicken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 g protein | Experimental | Dietary Supplement: whey protein25 g whey protein |
| 6.25 g protein supplemented with leucine | Experimental | Dietary Supplement: whey protein supplemented with leucine6.25 g protein supplemented with leucine |
| 6.25 g whey protein with EAA | Experimental | Dietary Supplement: whey protein supplemented with essential amino acids6.25 g protein supplemented with a mixture of essential amino acids devoid of leucine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male
- 18-35 years of age
- non-smoker/ non-tobacco product user
Key exclusion criteria (8 listed)
- heart disease
- vascular disease
- rheumatoid arthritis
- diabetes
- poor lung function
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 |
|---|---|---|
| whey proteinAlso: whey protein powder25 g whey protein | Dietary supplement | 25 g protein |
| whey protein supplemented with leucineAlso: whey protein powder supplemented with free-form leucine6.25 g whey protein supplemented with free form leucine | Dietary supplement | 6.25 g protein supplemented with leucine |
| whey protein supplemented with essential amino acidsAlso: whey protein supplemented with EAA devoid of leucine6.25 g whey protein supplemented with essential amino acids devoid of leucine | Dietary supplement | 6.25 g whey protein with EAA |
Primary outcome
Muscle protein synthesis
Time frame: 5 hours postprandial
Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound C13phe, by the enrichment of the precursor (= intracellular availability).
1 secondary outcome
Signaling molecule phosphorylation status
Time frame: 1, 3, and 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 24 Feb 2020.
- Derived from this study: PubMed 22451437Churchward-Venne TA, Burd NA, Mitchell CJ, West DW, Philp A, Marcotte GR, Baker SK, Baar K, Phillips SM. Supplementation of a suboptimal protein dose with leucine or essential amino acids: effects on myofibrillar protein synthesis at rest and following resistance exercise in men. J Physiol. 2012 Jun 1;590(11):2751-65. doi: 10.1113/jphysiol.2012.228833. Epub 2012 Mar 25.
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Not yet recruiting
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.
Stuart M Phillips, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein, whey protein supplemented with leucine and whey protein supplemented with essential amino acids in people with Regulation of Muscle Protein Synthesis, run by McMaster University at 1 site in Canada.
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 3 inclusion and 8 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 24 Feb 2020. 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 Canada. 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 (time frame: 5 hours postprandial). 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 NCT01492010, 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 24 Feb 2020.