HealthyNCT03319147
Effect of Amino Acid on Muscle Damage
A study testing Active in people with Healthy, run by University of Toronto at 1 site in Canada.
Trial summary
The primary objective is to determine the impact of essential amino acids on integrated muscle protein synthesis over 4 days after resistance exercise. In addition, the secondary objective is to determine the effect of essential amino acids on satellite cell regulation and inflammatory responses during this prolonged… 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
- Healthy
- What is being tested?
- Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 18 Oct 2017to 30 Oct 2019
- 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
- Healthy, male, recreationally-active participants
- Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix. B). Active will be defined as being in the top 20% of age specific scores on iPAQ (the International Physical Activity Questionnaire; Appendix.C).
- Participants are required not to engage in lower limb RT (resistance training) for at least 6 months prior to the study.
- Participants will be 18-35 years old.
- Participants are willing to abide by the compliance rules of this study
Who cannot join
- Female
- Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor
- Self-reported regular tobacco use
- Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.)
- The individual who has allergy for milk
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S2C9
About this study
Official title: Effect of Leucine-enriched Essential Amino Acid on Integrated Muscle Protein Synthesis and Muscle Recovery After Resistance Exercise
The primary objective is to determine the impact of essential amino acids on integrated muscle protein synthesis over 4 days after resistance exercise.
In addition, the secondary objective is to determine the effect of essential amino acids on satellite cell regulation and inflammatory responses during this prolonged recovery period.
- Conditions
- Healthy
- Being tested
- Active, Placebo
- Keywords
- exercise, recovery, muscle, protein
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDietary supplement
4g of essential amino acids
PlaceboDietary supplement
4g of maltdextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 4g of maltodextrin Receives: Dietary Supplement: Placebo |
| Active | Active comparator | 4g of essential amino acids Receives: Dietary Supplement: Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Skeletal muscle fractional synthesis rate (%/h) will be determined by oral pulse method using ring-[D5]phenylalanine
Measured: 4 hours
Secondary outcomes (3)
exercise performance
Maximal strength (torque in n-M) of the knee extensors will be assessed by a maximal isometric voluntary contraction (MVC).
Measured: 4 days
Muscle soreness
Corresponding subjective ratings of muscle soreness will be collected from participants using a visual analogue scale (mm)
Measured: 4 days
Muscle damage
Muscle damage will be determined by histochemical analysis. muscle damage is defined as Z-band streaming.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start18 Oct 2017
- Primary completion15 Jan 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319147
- Sponsor's protocol ID
- EAA
- Status last verified
- Apr 2021
- First submitted
- 18 Oct 2017
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Leucine-enriched Essential Amino Acid on Integrated Muscle Protein Synthesis and Muscle Recovery After Resistance Exercise
- ClinicalTrials.gov ID
- NCT03319147
- Acronym / sponsor ID
- EAA
- Conditions
- Healthy
- Keywords
- exercise, recovery, muscle, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 24 Oct 2017 (actual)
- 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.
The primary objective is to determine the impact of essential amino acids on integrated muscle protein synthesis over 4 days after resistance exercise.
In addition, the secondary objective is to determine the effect of essential amino acids on satellite cell regulation and inflammatory responses during this prolonged recovery period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo4g of maltodextrin |
| Active | Active comparator | Dietary Supplement: Active4g of essential amino acids |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, male, recreationally-active participants
- Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix. B). Active will be defined as being in the top 20% of age specific scores on iPAQ (the International Physical Activity Questionnaire; Appendix.C).
- Participants are required not to engage in lower limb RT (resistance training) for at least 6 months prior to the study.
- Participants will be 18-35 years old.
- Participants are willing to abide by the compliance rules of this study
Key exclusion criteria (5 listed)
- Female
- Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor
- Self-reported regular tobacco use
- Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.)
- The individual who has allergy for milk
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 |
|---|---|---|
| Active4g of essential amino acids | Dietary supplement | Active |
| Placebo4g of maltdextrin | Dietary supplement | Placebo |
Primary outcome
Muscle protein synthesis
Time frame: 4 hours
Skeletal muscle fractional synthesis rate (%/h) will be determined by oral pulse method using ring-[D5]phenylalanine
3 secondary outcomes
exercise performance
Time frame: 4 days
Muscle soreness
Time frame: 4 days
Muscle damage
Time frame: 4 days
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 20 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active in people with Healthy, run by University of Toronto 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 5 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 20 Apr 2021. 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. Some participants in this study may receive a placebo. 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: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2021.