Optimal Anabolic Nutrition InterventionsNCT01319513
Post-exercise Dietary Protein Strategies
A study testing whey protein bolus and whey protein pulses in people with Optimal Anabolic Nutrition Interventions, run by McMaster University at 1 site in Canada.
Trial summary
Protein ingestion increases the rate at which the body builds new proteins in skeletal muscle (muscle protein synthesis. This study is designed to examine how the pattern of feeding affects muscle protein synthesis following resistance exercise. 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
- Optimal Anabolic Nutrition Interventions
- What is being tested?
- whey protein bolus and whey protein pulses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Oct 2009
- 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
- Non-obese men (BMI <27) between the age of 18 and 35 yrs.
Who cannot join
- Type II diabetes or other known diseases
- Use of medication
- Female
- Other ages or BMI than indicated above
- Resistance training > 3X/wk
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ivor Wynne Centre A103, McMaster University
Hamilton, Ontario, L8S 4K1
About this study
Official title: The Effect of the Pattern Post-exercise Aminoacidemia on Myofibrillar Protein Synthesis
Protein ingestion increases the rate at which the body builds new proteins in skeletal muscle (muscle protein synthesis. This study is designed to examine how the pattern of feeding affects muscle protein synthesis following resistance exercise. There is reason to believe that the large rapid increase in blood amino acid concentrations that accompanies the ingestion of a bolus of protein is important to increasing muscle protein synthesis. Thus, we hypothesize that the consumption a bolus of protein will elevate muscle protein synthesis to a greater extent than the consumption of an equivalent amount of protein that is consumed in small divided doses.
Read the detailed description
The rapid appearance into the blood of essential amino acids, and leucine in particular, may act as an important signal to stimulate muscle protein synthesis after resistance exercise. This may explain why consuming rapidly-absorbed whey protein may have an anabolic edge over slowly-absorbed proteins such as casein. Previous investigations into importance of the rate of absorption to muscle protein synthesis that have used 'fast' and 'slow' proteins have been confounded by differences in amino acid composition. The present study addresses this issue by administering the same protein source, whey, as either a bolus or in small divided 'pulse' doses to achieve divergent amino acid profiles after a bout of resistance exercise.
This study is being conducted in young (18-35) men.
Our outcome measures include: blood amino acid concentrations, rates of myofibrillar protein synthesis, anabolic intracellular signalling markers
- Conditions
- Optimal Anabolic Nutrition Interventions
- Being tested
- whey protein bolus, whey protein pulses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey protein bolusOther
single dose of 25 g whey protein
whey protein pulsesOther
10 2.5 g pulses of whey protein
| Study group | Role | What they receive |
|---|---|---|
| protein feeding | Experimental | Participants will complete 2 trials in a cross-over fashion in which they will consume whey protein either as a single bolus or as 10 small divided doses Receives: Other: whey protein bolus; Other: whey protein pulses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of myofibrillar protein synthesis
Rates of myofibrillar protein synthesis will be measured from muscle biopsy samples obtained from subjects participating in the study protocol.
Measured: 4 months
Secondary outcomes (1)
Myocellular protein phosphorylation
Protein phosphorylation of target proteins will be measured from Western blot analysis of muscle biopsy samples.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionOct 2009
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 Optimal Anabolic Nutrition InterventionsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- RMIT University, Australian Institute of Sport, Nestec Ltd.
- Investigators
- Stuart M Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319513
- Sponsor's protocol ID
- Darwin 1a - Bolus versus Pulse
- Status last verified
- Mar 2011
- First submitted
- 18 Mar 2011
- Last updated
- 21 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
West DW, Burd NA, Coffey VG, Baker SK, Burke LM, Hawley JA, Moore DR, Stellingwerff T, Phillips SM. Rapid aminoacidemia enhances myofibrillar protein synthesis and anabolic intramuscular signaling responses after resistance exercise. Am J Clin Nutr. 2011 Sep;94(3):795-803. doi: 10.3945/ajcn.111.013722. Epub 2011 Jul 27.
PubMed 21795443
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Pattern Post-exercise Aminoacidemia on Myofibrillar Protein Synthesis
- ClinicalTrials.gov ID
- NCT01319513
- Acronym / sponsor ID
- Darwin 1a - Bolus versus Pulse
- Conditions
- Optimal Anabolic Nutrition Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- RMIT University, Australian Institute of Sport, Nestec Ltd.
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Mar 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.
Protein ingestion increases the rate at which the body builds new proteins in skeletal muscle (muscle protein synthesis. This study is designed to examine how the pattern of feeding affects muscle protein synthesis following resistance exercise. There is reason to believe that the large rapid increase in blood amino acid concentrations that accompanies the ingestion of a bolus of protein is important to increasing muscle protein synthesis. Thus, we hypothesize that the consumption a bolus of protein will elevate muscle protein synthesis to a greater extent than the consumption of an equivalent amount of protein that is consumed in small divided doses.
Detailed description
The rapid appearance into the blood of essential amino acids, and leucine in particular, may act as an important signal to stimulate muscle protein synthesis after resistance exercise. This may explain why consuming rapidly-absorbed whey protein may have an anabolic edge over slowly-absorbed proteins such as casein. Previous investigations into importance of the rate of absorption to muscle protein synthesis that have used 'fast' and 'slow' proteins have been confounded by differences in amino acid composition. The present study addresses this issue by administering the same protein source, whey, as either a bolus or in small divided 'pulse' doses to achieve divergent amino acid profiles after a bout of resistance exercise.
This study is being conducted in young (18-35) men.
Our outcome measures include: blood amino acid concentrations, rates of myofibrillar protein synthesis, anabolic intracellular signalling markers
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| protein feeding | Experimental | Other: whey protein bolus, Other: whey protein pulsesParticipants will complete 2 trials in a cross-over fashion in which they will consume whey protein either as a single bolus or as 10 small divided doses |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-obese men (BMI <27) between the age of 18 and 35 yrs.
Key exclusion criteria (5 listed)
- Type II diabetes or other known diseases
- Use of medication
- Female
- Other ages or BMI than indicated above
- Resistance training > 3X/wk
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 protein bolussingle dose of 25 g whey protein | Other | protein feeding |
| whey protein pulses10 2.5 g pulses of whey protein | Other | protein feeding |
Primary outcome
Rate of myofibrillar protein synthesis
Time frame: 4 months
Rates of myofibrillar protein synthesis will be measured from muscle biopsy samples obtained from subjects participating in the study protocol.
1 secondary outcome
Myocellular protein phosphorylation
Time frame: 4 months
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 21 Mar 2011.
- Derived from this study: PubMed 21795443West DW, Burd NA, Coffey VG, Baker SK, Burke LM, Hawley JA, Moore DR, Stellingwerff T, Phillips SM. Rapid aminoacidemia enhances myofibrillar protein synthesis and anabolic intramuscular signaling responses after resistance exercise. Am J Clin Nutr. 2011 Sep;94(3):795-803. doi: 10.3945/ajcn.111.013722. Epub 2011 Jul 27.
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 bolus and whey protein pulses in people with Optimal Anabolic Nutrition Interventions, 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 1 inclusion and 5 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 21 Mar 2011. 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?
Rate of myofibrillar protein synthesis (time frame: 4 months). 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 NCT01319513, 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 21 Mar 2011.