Effect of Amino Acid on Muscle Damage | NCT03319147

Studies
Effect of Amino Acid on Muscle Damage

NCT03319147

Sponsor

University of Toronto

Status

Completed

Last Update Posted

Apr 20, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Active
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 18, 2017Actual

Primary Completion Date

Jan 15, 2019Actual

Completion Date

Oct 30, 2019Actual

First Submitted Date

Oct 18, 2017

First Submission Date that Met QC Criteria

Oct 18, 2017

First Posted Date

Oct 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2021

Last Update Posted Date

Apr 20, 2021Actual

Name	Class
Ajinomoto Co., Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	4g of maltodextrin	Dietary Supplement: Placebo
Active	Active Comparator	4g of essential amino acids	Dietary Supplement: Active

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active	Dietary Supplement	4g of essential amino acids	Active
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle protein synthesis	Skeletal muscle fractional synthesis rate (%/h) will be determined by oral pulse method using ring-[D5]phenylalanine	4 hours

Secondary Outcomes

Measure	Description	Time Frame
exercise performance	Maximal strength (torque in n-M) of the knee extensors will be assessed by a maximal isometric voluntary contraction (MVC).	4 days
Muscle soreness	Corresponding subjective ratings of muscle soreness will be collected from participants using a visual analogue scale (mm)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goldring Centre for High Performance Sport		Toronto	Ontario	M5S2C9	Canada

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided