Amino Acids, EssentialB2BNCT04850820
Impact of Amino Acids to Enhance Anabolism After Home-based Exercise
A study testing Novel essential amino acid supplementation, Branched-chain amino acid supplementation (BCAA) and Isocaloric carbohydrate supplementation in people with Amino Acids, Essential and Metabolism, run by University of Toronto at 1 site in Canada.
Trial summary
An adequate quantity of lean body mass is vital for optimal health and performance, and is accrued when net protein balance (NPB) is positive. Amino acids are the building blocks of protein, and when consumed following resistance exercise, significantly improve NPB. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acids, Essential, Metabolism, Exercise
- What is being tested?
- Novel essential amino acid supplementation, Branched-chain amino acid supplementation (BCAA) and Isocaloric carbohydrate supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2021to 31 Dec 2021
- 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
- Aged 18-35 years
- Recreationally active; currently performing structured exercise (e.g., running, weight lifting, team-sport activity) at least 2 days per week
Who cannot join
- Body Mass Index: >29.9kg/m^2
- Inability to perform physical activity as determined by the Physical Activity Readiness Questionnaire
- Inability to adhere to protocol guidelines (e.g., alcohol, habitual diet)
- Regular tobacco use
- Illicit drug use (e.g., growth hormone, testosterone)
- Diagnosed medical condition under the care of a physician
- Inability to abstain from supplements (e.g., protein, creatine, HMB, BCAA, phosphatidic acid) at least three weeks before and during trials
- Individuals on any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S2C9
About this study
An adequate quantity of lean body mass is vital for optimal health and performance, and is accrued when net protein balance (NPB) is positive. Amino acids are the building blocks of protein, and when consumed following resistance exercise, significantly improve NPB.
However, no study has investigated how a supplement of all of the essential amino acids (EAA) affects NPB following resistance exercise in a free-living, home-based setting, particularly when compared to a supplement of branched-chain amino acids (BCAA).
Therefore, the purpose of this study is to determine the impact of a novel EAA supplement on anabolism (e.g., NPB) as compared to BCAA and placebo supplements following home-based resistance exercise.
- Conditions
- Amino Acids, Essential, Metabolism, Exercise
- Being tested
- Novel essential amino acid supplementation, Branched-chain amino acid supplementation (BCAA), Isocaloric carbohydrate supplementation
- Keywords
- Home-based resistance exercise, Protein synthesis, Net protein balance, Protein breakdown, Essential amino acids, Branched-chain amino acids, Protein metabolism
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel essential amino acid supplementationDietary supplement
This intervention will determine the impact of EAA+ on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.
Branched-chain amino acid supplementation (BCAA)Dietary supplement
This intervention will determine the impact of the BCAA supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.
Isocaloric carbohydrate supplementationDietary supplement
This intervention will determine the impact of an isocaloric carbohydrate placebo supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.
| Study group | Role | What they receive |
|---|---|---|
| Novel essential amino acid supplementation (EAA+) | Experimental | Arm will investigate the effect of a novel essential amino acid-based formula (essential amino acids enriched with active botanical compounds; EAA+) developed by Iovate Health Sciences International Inc. on post-exercise anabolism. The formulation was recently granted a Natural Product Number (NPN: 80087022) and approved by the Natural and Non-prescription Health Products Directorate of Health Canada. Receives: Dietary Supplement: Novel essential amino acid supplementation |
| Branched-chain amino acid supplementation (BCAA) | Active comparator | Arm will used a branched-chain amino acid supplement developed by Iovate Health Sciences International Inc. to compare with the experimental arm after exercise. Receives: Dietary Supplement: Branched-chain amino acid supplementation (BCAA) |
| Isocaloric carbohydrate supplementation | Placebo comparator | Carbohydrate supplement that is isocaloric to the EAA+ supplement and designed to function as a placebo to the experimental arm after exercise. Receives: Dietary Supplement: Isocaloric carbohydrate supplementation |
| Rested control | Other | Carbohydrate supplement that is isocaloric to the EAA+ supplement but consumed at rest to serve as the baseline control Receives: Dietary Supplement: Isocaloric carbohydrate supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body net leucine balance (umol/kg)
Used as a proxy of whole-body protein balance, and estimated by using [13C]leucine ingestion and breath/urine sample collection
Measured: 5 hours/trial (four trials total)
Secondary outcomes (1)
Urinary 3-methylhistidine (3-methylhistidine:creatinine ratio)
Used as a marker of muscle protein breakdown by measuring the 3-methylhistidine:creatinine ratio in the urine
Measured: 5 hours/trial (four trials total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino Acids, EssentialStudies 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
- Crossover
- Model description
- In a randomized, counterbalanced order, participants will receive all treatments arms (essential amino acids, branched-chain amino acids, and placebo).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Daniel Moore, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850820
- Sponsor's protocol ID
- B2B
- Acronym
- B2B
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Amino Acids to Enhance Anabolism After Home-based Exercise
- ClinicalTrials.gov ID
- NCT04850820
- Acronym / sponsor ID
- B2B / B2B
- Conditions
- Amino Acids, Essential, Metabolism, Exercise
- Keywords
- Home-based resistance exercise, Protein synthesis, Net protein balance, Protein breakdown, Essential amino acids, Branched-chain amino acids, Protein metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Apr 2021 (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.
An adequate quantity of lean body mass is vital for optimal health and performance, and is accrued when net protein balance (NPB) is positive. Amino acids are the building blocks of protein, and when consumed following resistance exercise, significantly improve NPB.
However, no study has investigated how a supplement of all of the essential amino acids (EAA) affects NPB following resistance exercise in a free-living, home-based setting, particularly when compared to a supplement of branched-chain amino acids (BCAA).
Therefore, the purpose of this study is to determine the impact of a novel EAA supplement on anabolism (e.g., NPB) as compared to BCAA and placebo supplements following home-based resistance exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- In a randomized, counterbalanced order, participants will receive all treatments arms (essential amino acids, branched-chain amino acids, and placebo).
| Arm | Type | Receives |
|---|---|---|
| Novel essential amino acid supplementation (EAA+) | Experimental | Dietary Supplement: Novel essential amino acid supplementationArm will investigate the effect of a novel essential amino acid-based formula (essential amino acids enriched with active botanical compounds; EAA+) developed by Iovate Health Sciences International Inc. on post-exercise anabolism. The formulation was recently granted a Natural Product Number (NPN: 80087022) and approved by the Natural and Non-prescription Health Products Directorate of Health Canada. |
| Branched-chain amino acid supplementation (BCAA) | Active comparator | Dietary Supplement: Branched-chain amino acid supplementation (BCAA)Arm will used a branched-chain amino acid supplement developed by Iovate Health Sciences International Inc. to compare with the experimental arm after exercise. |
| Isocaloric carbohydrate supplementation | Placebo comparator | Dietary Supplement: Isocaloric carbohydrate supplementationCarbohydrate supplement that is isocaloric to the EAA+ supplement and designed to function as a placebo to the experimental arm after exercise. |
| Rested control | Other | Dietary Supplement: Isocaloric carbohydrate supplementationCarbohydrate supplement that is isocaloric to the EAA+ supplement but consumed at rest to serve as the baseline control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-35 years
- Recreationally active; currently performing structured exercise (e.g., running, weight lifting, team-sport activity) at least 2 days per week
Key exclusion criteria (8 listed)
- Body Mass Index: >29.9kg/m^2
- Inability to perform physical activity as determined by the Physical Activity Readiness Questionnaire
- Inability to adhere to protocol guidelines (e.g., alcohol, habitual diet)
- Regular tobacco use
- Illicit drug use (e.g., growth hormone, testosterone)
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 |
|---|---|---|
| Novel essential amino acid supplementationThis intervention will determine the impact of EAA+ on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting. | Dietary supplement | Novel essential amino acid supplementation (EAA+) |
| Branched-chain amino acid supplementation (BCAA)This intervention will determine the impact of the BCAA supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting. | Dietary supplement | Branched-chain amino acid supplementation (BCAA) |
| Isocaloric carbohydrate supplementationThis intervention will determine the impact of an isocaloric carbohydrate placebo supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting. | Dietary supplement | Isocaloric carbohydrate supplementation, Rested control |
Primary outcome
Whole-body net leucine balance (umol/kg)
Time frame: 5 hours/trial (four trials total)
Used as a proxy of whole-body protein balance, and estimated by using [13C]leucine ingestion and breath/urine sample collection
1 secondary outcome
Urinary 3-methylhistidine (3-methylhistidine:creatinine ratio)
Time frame: 5 hours/trial (four trials total)
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 5 May 2022.
- Individual participant dataSharing planned: No
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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.
Daniel Moore principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel essential amino acid supplementation, Branched-chain amino acid supplementation (BCAA) and Isocaloric carbohydrate supplementation in people with Amino Acids, Essential and Metabolism, 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 2 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 5 May 2022. 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?
Whole-body net leucine balance (umol/kg) (time frame: 5 hours/trial (four trials total)). 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 5 May 2022.