- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03319147
Effect of Amino Acid on Muscle Damage
April 17, 2021 updated by: Daniel Moore, University of Toronto
Effect of Leucine-enriched Essential Amino Acid on Integrated Muscle Protein Synthesis and Muscle Recovery After Resistance Exercise
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
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
Yes
Genders Eligible for Study
Male
Description
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
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
4g of maltodextrin
|
4g of maltdextrin
|
Active Comparator: Active
4g of essential amino acids
|
4g of essential amino acids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle protein synthesis
Time Frame: 4 hours
|
Skeletal muscle fractional synthesis rate (%/h) will be determined by oral pulse method using ring-[D5]phenylalanine
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exercise performance
Time Frame: 4 days
|
Maximal strength (torque in n-M) of the knee extensors will be assessed by a maximal isometric voluntary contraction (MVC).
|
4 days
|
Muscle soreness
Time Frame: 4 days
|
Corresponding subjective ratings of muscle soreness will be collected from participants using a visual analogue scale (mm)
|
4 days
|
Muscle damage
Time Frame: 4 days
|
Muscle damage will be determined by histochemical analysis.
muscle damage is defined as Z-band streaming.
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
October 18, 2017
Primary Completion (Actual)
January 15, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
October 18, 2017
First Submitted That Met QC Criteria
October 18, 2017
First Posted (Actual)
October 24, 2017
Study Record Updates
Last Update Posted (Actual)
April 20, 2021
Last Update Submitted That Met QC Criteria
April 17, 2021
Last Verified
April 1, 2021
More Information
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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