- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04850820
Impact of Amino Acids to Enhance Anabolism After Home-based Exercise (B2B)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S2C9
- Goldring Centre for High Performance Sport
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-35 years
- Recreationally active; currently performing structured exercise (e.g., running, weight lifting, team-sport activity) at least 2 days per week
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Novel essential amino acid supplementation (EAA+)
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.
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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.
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Active Comparator: 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.
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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.
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Placebo Comparator: Isocaloric carbohydrate supplementation
Carbohydrate supplement that is isocaloric to the EAA+ supplement and designed to function as a placebo to the experimental arm after exercise.
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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.
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Other: Rested control
Carbohydrate supplement that is isocaloric to the EAA+ supplement but consumed at rest to serve as the baseline control
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole-body net leucine balance (umol/kg)
Time Frame: 5 hours/trial (four trials total)
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Used as a proxy of whole-body protein balance, and estimated by using [13C]leucine ingestion and breath/urine sample collection
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5 hours/trial (four trials total)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary 3-methylhistidine (3-methylhistidine:creatinine ratio)
Time Frame: 5 hours/trial (four trials total)
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Used as a marker of muscle protein breakdown by measuring the 3-methylhistidine:creatinine ratio in the urine
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5 hours/trial (four trials total)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Moore, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B2B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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