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

April 29, 2022 updated by: Daniel Moore, University of Toronto

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S2C9
        • Goldring Centre for High Performance Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.
Other: Rested control
Carbohydrate supplement that is isocaloric to the EAA+ supplement but consumed at rest to serve as the baseline control
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.

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)
Used as a proxy of whole-body protein balance, and estimated by using [13C]leucine ingestion and breath/urine sample collection
5 hours/trial (four trials total)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 hours/trial (four trials total)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Moore, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 17, 2021

First Submitted That Met QC Criteria

April 17, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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