NCT04850820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

April 17, 2021

Last Update Submit

April 29, 2022

Conditions

Keywords

Home-based resistance exerciseProtein synthesisNet protein balanceProtein breakdownEssential amino acidsBranched-chain amino acidsProtein metabolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Urinary 3-methylhistidine (3-methylhistidine:creatinine ratio)

    5 hours/trial (four trials total)

Study Arms (4)

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.

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.

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.

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

Dietary Supplement: Isocaloric carbohydrate supplementation

Interventions

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.

Novel essential amino acid supplementation (EAA+)

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.

Branched-chain amino acid supplementation (BCAA)

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.

Isocaloric carbohydrate supplementationRested control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-35 years
  • Recreationally active; currently performing structured exercise (e.g., running, weight lifting, team-sport activity) at least 2 days per week

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S2C9, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Daniel Moore

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All investigators involved with the study, as well as participants, will be blinded to treatment conditions (double-blind design) until data analysis is completed.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: In a randomized, counterbalanced order, participants will receive all treatments arms (essential amino acids, branched-chain amino acids, and placebo).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 17, 2021

First Posted

April 20, 2021

Study Start

April 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations