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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04850820
Other study ID # B2B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date December 31, 2021

Study information

Verified date April 2022
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Canada Goldring Centre for High Performance Sport Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto Iovate Health Sciences International Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 5 hours/trial (four trials total)
Secondary 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 5 hours/trial (four trials total)
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