NCT03319147

Brief Summary

The primary objective is to determine the impact of essential amino acids on integrated muscle protein synthesis over 4 days after resistance exercise. In addition, the secondary objective is to determine the effect of essential amino acids on satellite cell regulation and inflammatory responses during this prolonged recovery period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable healthy

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

First Submitted

Initial submission to the registry

October 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

October 18, 2017

Last Update Submit

April 17, 2021

Conditions

Keywords

exerciserecoverymuscleprotein

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis

    Skeletal muscle fractional synthesis rate (%/h) will be determined by oral pulse method using ring-\[D5\]phenylalanine

    4 hours

Secondary Outcomes (3)

  • exercise performance

    4 days

  • Muscle soreness

    4 days

  • Muscle damage

    4 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

4g of maltodextrin

Dietary Supplement: Placebo

Active

ACTIVE COMPARATOR

4g of essential amino acids

Dietary Supplement: Active

Interventions

ActiveDIETARY_SUPPLEMENT

4g of essential amino acids

Active
PlaceboDIETARY_SUPPLEMENT

4g of maltdextrin

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy, male, recreationally-active participants
  • Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix. B). Active will be defined as being in the top 20% of age specific scores on iPAQ (the International Physical Activity Questionnaire; Appendix.C).
  • Participants are required not to engage in lower limb RT (resistance training) for at least 6 months prior to the study.
  • Participants will be 18-35 years old.
  • Participants are willing to abide by the compliance rules of this study

You may not qualify if:

  • Female
  • Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor
  • Self-reported regular tobacco use
  • Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.)
  • The individual who has allergy for milk

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

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 24, 2017

Study Start

October 18, 2017

Primary Completion

January 15, 2019

Study Completion

October 30, 2019

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations