Effects of Essential and Non-Essential Amino Acids on Post-Exercise Muscle Collagen Synthesis in Young Men (PECS)

June 9, 2023 updated by: Cameron Mitchell, University of British Columbia

The Effects of Essential and Non-Essential Amino Acids on Post-Exercise Muscle Collagen Synthesis in Young Men: a Randomized Controlled Trial

The purpose of this study is to assess which amino acids are affecting acute muscle collagen synthesis in response to supplementation and exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a double-blinded, randomized controlled, parallel design study, with 3 treatment groups (placebo, collagen peptide, and essential amino acid). The study will involve 3 visits: a baseline testing/familiarization session, and 2 exercise trials which will include muscle biopsies, blood draws, and the infusion of a tracer isotope in order to measure muscle protein synthesis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Chan Gunn Pavilion

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Can fluently read and write in English
  • Male
  • 18 - 35 years

Exclusion Criteria:

  • Diabetes, cardiovascular disease, or current pharmaceutical therapy
  • Medical conditions impacting ability to undertake strenuous physical activity
  • Lower body resistance training in the previous 6 months
  • BMI > 30
  • Currently smoking with cigarettes
  • Allergy to any study supplements
  • Currently taking any protein, amino acid, or collagen supplement
  • Participate in greater than 2 hours of weekly vigorous exercise

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Essential Amino Acid
Participants will consume 1 dose of: 15 g crystalline essential amino acid supplement (Pure Encapsulation Essential Aminos 180) + 80 ml (48 mg) Vitamin C (Ribena Blackcurrant) + 250 ml water
Dietary supplement: Essential Amino Acid
Immediately following the exercise intervention participants will consume their assigned essential amino acid supplement
Active Comparator: Collagen Peptide
Participants will consume 1 dose of: 15g collagen peptide (Gelita TENDOFORTE) + 80 ml (48 mg) Vitamin C (Ribena Blackcurrant) + 250 ml water
Dietary supplement: Collagen Peptide
Immediately following the exercise intervention participants will consume their assigned collagen peptide supplement
Placebo Comparator: Maltodextrin Placebo
Participants will consume 1 dose of:15 g maltodextrin (Canadian Protein Maltodextrin) + 80 ml (48 mg) Vitamin C (Ribena Blackcurrant) + 250 ml water
Dietary supplement: Maltodextrin Placebo
Immediately following the exercise intervention participants will consume their assigned maltodextrin supplement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fractional synthetic rate (change over time) of Myofibrillar Protein Synthesis
Time Frame: 0 - 4 hours post-exercise
Fraction of the myofibrillar enriched protein from muscle biopsy per unit time.
0 - 4 hours post-exercise
Fractional synthetic rate (change over time) of Myofibrillar Protein Synthesis
Time Frame: 0 - 2 hours post-exercise
Fraction of the myofibrillar enriched protein from muscle biopsy per unit time.
0 - 2 hours post-exercise
Fractional synthetic rate (change over time) of Myofibrillar Protein Synthesis
Time Frame: 2 - 4 hours post-exercise
Fraction of the myofibrillar enriched protein from muscle biopsy per unit time.
2 - 4 hours post-exercise
Fractional synthetic rate (change over time) Muscle Collagen Synthesis
Time Frame: 0 - 4 hours post-exercise
Fraction of the intramuscular collagen enriched protein from muscle biopsy per unit time.
0 - 4 hours post-exercise
Fractional synthetic rate (change over time) Muscle Collagen Synthesis
Time Frame: 0 - 2 hours post-exercise
Fraction of the intramuscular collagen enriched protein from muscle biopsy per unit time.
0 - 2 hours post-exercise
Fractional synthetic rate (change over time) Muscle Collagen Synthesis
Time Frame: 2 - 4 hours post-exercise
Fraction of the intramuscular collagen enriched protein from muscle biopsy per unit time.
2 - 4 hours post-exercise
Pro-Collagen Type I N-Propeptide (PINP)
Time Frame: 1 hour prior to exercise
Osteoblastic marker of bone collagen synthesis
1 hour prior to exercise
Pro-Collagen Type I N-Propeptide (PINP)
Time Frame: 4 hours post exercise
Osteoblastic marker of bone collagen synthesis
4 hours post exercise

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Amino Acids Response to Supplementation
Time Frame: 0 - 4 hours post-exercise
Amino acid plasma concentrations
0 - 4 hours post-exercise
Muscle mechanistic target of rapamycin Pathway Activation
Time Frame: 0 - 4 hours post-exercise
Measuring the fold change in enzymes associated with the anabolic signalling of the mTOR pathway (e.g. phosphoinositide 3-kinases (PI3k), protein kinase B (Akt))
0 - 4 hours post-exercise
PCR Gene Expression of Muscle Collagen Genes (Types I, III, IV)
Time Frame: 0 - 4 hours post-exercise
Measuring the fold change when the collagen genes of interest become detectable in the PCR analysis
0 - 4 hours post-exercise
Pro-Collagen Type III N-Propeptide (PIIINP)
Time Frame: 1 hour prior to exercise
Marker of collagen synthesis
1 hour prior to exercise
Pro-Collagen Type III N-Propeptide (PIIINP)
Time Frame: 4 hours post exercise
Marker of collagen synthesis
4 hours post exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cameron Mitchell, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H20-00943

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings