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Impact of Amino Acids to Enhance Anabolism After Home-based Exercise (B2B)

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ClinicalTrials.gov Identifier: NCT04850820
Recruitment Status : Completed
First Posted : April 20, 2021
Last Update Posted : May 5, 2022
Sponsor:
Collaborator:
Iovate Health Sciences International Inc
Information provided by (Responsible Party):
Daniel Moore, University of Toronto

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Amino Acids, Essential Metabolism Exercise Dietary Supplement: Novel essential amino acid supplementation Dietary Supplement: Branched-chain amino acid supplementation (BCAA) Dietary Supplement: Isocaloric carbohydrate supplementation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: In a randomized, counterbalanced order, participants will receive all treatments arms (essential amino acids, branched-chain amino acids, and placebo).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: All investigators involved with the study, as well as participants, will be blinded to treatment conditions (double-blind design) until data analysis is completed.
Primary Purpose: Basic Science
Official Title: Impact of Amino Acids to Enhance Anabolism After Home-based Exercise
Actual Study Start Date : April 1, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Dietary Supplement: Novel essential amino acid supplementation
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.
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.
 Dietary Supplement: 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.
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.
 Dietary Supplement: Isocaloric carbohydrate supplementation
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.
Rested control
Carbohydrate supplement that is isocaloric to the EAA+ supplement but consumed at rest to serve as the baseline control
 Dietary Supplement: Isocaloric carbohydrate supplementation
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Urinary 3-methylhistidine (3-methylhistidine:creatinine ratio) [ Time Frame: 5 hours/trial (four trials total) ]
    Used as a marker of muscle protein breakdown by measuring the 3-methylhistidine:creatinine ratio in the urine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850820


Locations
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Canada, Ontario
Goldring Centre for High Performance Sport
Toronto, Ontario, Canada, M5S2C9
Sponsors and Collaborators
University of Toronto
Iovate Health Sciences International Inc
Investigators
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Principal Investigator: Daniel Moore University of Toronto
More Information
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Responsible Party: Daniel Moore, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT04850820    
Other Study ID Numbers: B2B
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Moore, University of Toronto:
Home-based resistance exercise
Protein synthesis
Net protein balance
Protein breakdown
 Essential amino acids
Branched-chain amino acids
Protein metabolism