- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04596553
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
Completed
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
Interventional
Enrollment (Actual)
17
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 Contact
- Name: Jordan Stevenson, BSc
- Phone Number: 289-264-0295
- Email: jordan.stevenson@ubc.ca
Study Contact Backup
- Name: Cameron Mitchell, PhD
- Phone Number: 604-827-2072
- Email: cameron.mitchell@ubc.ca
Study Locations
-
-
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
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 |
Intervention / Treatment |
---|---|
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
|
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
|
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
|
Immediately following the exercise intervention participants will consume their assigned maltodextrin supplement
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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
- Miller BF, Olesen JL, Hansen M, Dossing S, Crameri RM, Welling RJ, Langberg H, Flyvbjerg A, Kjaer M, Babraj JA, Smith K, Rennie MJ. Coordinated collagen and muscle protein synthesis in human patella tendon and quadriceps muscle after exercise. J Physiol. 2005 Sep 15;567(Pt 3):1021-33. doi: 10.1113/jphysiol.2005.093690. Epub 2005 Jul 7.
- Shaw G, Lee-Barthel A, Ross ML, Wang B, Baar K. Vitamin C-enriched gelatin supplementation before intermittent activity augments collagen synthesis. Am J Clin Nutr. 2017 Jan;105(1):136-143. doi: 10.3945/ajcn.116.138594. Epub 2016 Nov 16.
- Holm L, Rahbek SK, Farup J, Vendelbo MH, Vissing K. Contraction mode and whey protein intake affect the synthesis rate of intramuscular connective tissue. Muscle Nerve. 2017 Jan;55(1):128-130. doi: 10.1002/mus.25398. Epub 2016 Sep 26.
- Frontera WR, Ochala J. Skeletal muscle: a brief review of structure and function. Calcif Tissue Int. 2015 Mar;96(3):183-95. doi: 10.1007/s00223-014-9915-y. Epub 2014 Oct 8.
- Egerman MA, Glass DJ. Signaling pathways controlling skeletal muscle mass. Crit Rev Biochem Mol Biol. 2014 Jan-Feb;49(1):59-68. doi: 10.3109/10409238.2013.857291. Epub 2013 Nov 18.
- Holm L, van Hall G, Rose AJ, Miller BF, Doessing S, Richter EA, Kjaer M. Contraction intensity and feeding affect collagen and myofibrillar protein synthesis rates differently in human skeletal muscle. Am J Physiol Endocrinol Metab. 2010 Feb;298(2):E257-69. doi: 10.1152/ajpendo.00609.2009. Epub 2009 Nov 10.
- Alcock RD, Shaw GC, Tee N, Burke LM. Plasma Amino Acid Concentrations After the Ingestion of Dairy and Collagen Proteins, in Healthy Active Males. Front Nutr. 2019 Oct 15;6:163. doi: 10.3389/fnut.2019.00163. eCollection 2019.
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)
January 25, 2021
Primary Completion (Actual)
February 13, 2022
Study Completion (Actual)
February 13, 2022
Study Registration Dates
First Submitted
September 28, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID 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.
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