Skeletal MusclePECSNCT04596553
Effects of Essential and Non-Essential Amino Acids on Post-Exercise Muscle Collagen Synthesis in Young Men
A study testing Essential Amino Acid and Collagen Peptide in people with Skeletal Muscle and Extracellular Matrix, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to assess which amino acids are affecting acute muscle collagen synthesis in response to supplementation and exercise. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle, Extracellular Matrix, Amino Acids Metabolism
- What is being tested?
- Essential Amino Acid and Collagen Peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2021to 13 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Can fluently read and write in English
- Male
- 18 - 35 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Skeletal Muscle, Extracellular Matrix, Amino Acids Metabolism, Exercise, Dietary Supplements
- Being tested
- Essential Amino Acid, Collagen Peptide, Maltodextrin Placebo
- Keywords
- Muscle Collagen Turnover, Myofibrillar Protein Synthesis, Extracellular Matrix, Anabolism Signaling, Resistance Exercise, Skeletal Muscle, Bone Turnover
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Amino AcidDietary supplement
Immediately following the exercise intervention participants will consume their assigned essential amino acid supplement
Collagen PeptideDietary supplement
Immediately following the exercise intervention participants will consume their assigned collagen peptide supplement
Maltodextrin PlaceboDietary supplement
Immediately following the exercise intervention participants will consume their assigned maltodextrin supplement
| Study group | Role | What they receive |
|---|---|---|
| Essential Amino Acid | Active comparator | 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 Receives: Dietary Supplement: Essential Amino Acid |
| Collagen Peptide | Active comparator | Participants will consume 1 dose of: 15g collagen peptide (Gelita TENDOFORTE) + 80 ml (48 mg) Vitamin C (Ribena Blackcurrant) + 250 ml water Receives: Dietary Supplement: Collagen Peptide |
| Maltodextrin Placebo | Placebo comparator | Participants will consume 1 dose of:15 g maltodextrin (Canadian Protein Maltodextrin) + 80 ml (48 mg) Vitamin C (Ribena Blackcurrant) + 250 ml water Receives: Dietary Supplement: Maltodextrin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthetic rate (change over time) of Myofibrillar Protein Synthesis
Fraction of the myofibrillar enriched protein from muscle biopsy per unit time.
Measured: 0 - 4 hours post-exercise
Fractional synthetic rate (change over time) of Myofibrillar Protein Synthesis
Fraction of the myofibrillar enriched protein from muscle biopsy per unit time.
Measured: 0 - 2 hours post-exercise
Fractional synthetic rate (change over time) of Myofibrillar Protein Synthesis
Fraction of the myofibrillar enriched protein from muscle biopsy per unit time.
Measured: 2 - 4 hours post-exercise
Fractional synthetic rate (change over time) Muscle Collagen Synthesis
Fraction of the intramuscular collagen enriched protein from muscle biopsy per unit time.
Measured: 0 - 4 hours post-exercise
Fractional synthetic rate (change over time) Muscle Collagen Synthesis
Fraction of the intramuscular collagen enriched protein from muscle biopsy per unit time.
Measured: 0 - 2 hours post-exercise
Fractional synthetic rate (change over time) Muscle Collagen Synthesis
Fraction of the intramuscular collagen enriched protein from muscle biopsy per unit time.
Measured: 2 - 4 hours post-exercise
Pro-Collagen Type I N-Propeptide (PINP)
Osteoblastic marker of bone collagen synthesis
Measured: 1 hour prior to exercise
Pro-Collagen Type I N-Propeptide (PINP)
Osteoblastic marker of bone collagen synthesis
Measured: 4 hours post exercise
Secondary outcomes (5)
Plasma Amino Acids Response to Supplementation
Amino acid plasma concentrations
Measured: 0 - 4 hours post-exercise
Muscle mechanistic target of rapamycin Pathway Activation
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))
Measured: 0 - 4 hours post-exercise
PCR Gene Expression of Muscle Collagen Genes (Types I, III, IV)
Measuring the fold change when the collagen genes of interest become detectable in the PCR analysis
Measured: 0 - 4 hours post-exercise
Pro-Collagen Type III N-Propeptide (PIIINP)
Marker of collagen synthesis
Measured: 1 hour prior to exercise
Pro-Collagen Type III N-Propeptide (PIIINP)
Marker of collagen synthesis
Measured: 4 hours post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start25 Jan 2021
- Primary completion13 Feb 2022
- Study completion13 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Skeletal MuscleStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- \- Double-blinded, randomized controlled, parallel design study, with 3 treatment groups (placebo, collagen peptide, and essential amino acid)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameron Mitchell, University of British Columbia
- Investigators
- Cameron Mitchell, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596553
- Sponsor's protocol ID
- H20-00943
- Acronym
- PECS
- Status last verified
- Jun 2023
- First submitted
- 28 Sep 2020
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27852613Holm 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.
PubMed 27603578Frontera 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.
PubMed 25294644Egerman 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.
PubMed 24237131Holm 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.
PubMed 19903866Alcock 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.
PubMed 31681789Miller 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.
PubMed 16002437
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Essential and Non-Essential Amino Acids on Post-Exercise Muscle Collagen Synthesis in Young Men: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04596553
- Acronym / sponsor ID
- PECS / H20-00943
- Conditions
- Skeletal Muscle, Extracellular Matrix, Amino Acids Metabolism, Exercise, Dietary Supplements
- Keywords
- Muscle Collagen Turnover, Myofibrillar Protein Synthesis, Extracellular Matrix, Anabolism Signaling, Resistance Exercise, Skeletal Muscle, Bone Turnover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 13 Feb 2022 (actual)
- Study completion
- 13 Feb 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess which amino acids are affecting acute muscle collagen synthesis in response to supplementation 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- - Double-blinded, randomized controlled, parallel design study, with 3 treatment groups (placebo, collagen peptide, and essential amino acid)
| Arm | Type | Receives |
|---|---|---|
| Essential Amino Acid | Active comparator | Dietary Supplement: Essential Amino AcidParticipants 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 |
| Collagen Peptide | Active comparator | Dietary Supplement: Collagen PeptideParticipants will consume 1 dose of: 15g collagen peptide (Gelita TENDOFORTE) + 80 ml (48 mg) Vitamin C (Ribena Blackcurrant) + 250 ml water |
| Maltodextrin Placebo | Placebo comparator | Dietary Supplement: Maltodextrin PlaceboParticipants will consume 1 dose of:15 g maltodextrin (Canadian Protein Maltodextrin) + 80 ml (48 mg) Vitamin C (Ribena Blackcurrant) + 250 ml water |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Can fluently read and write in English
- Male
- 18 - 35 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential Amino AcidImmediately following the exercise intervention participants will consume their assigned essential amino acid supplement | Dietary supplement | Essential Amino Acid |
| Collagen PeptideImmediately following the exercise intervention participants will consume their assigned collagen peptide supplement | Dietary supplement | Collagen Peptide |
| Maltodextrin PlaceboImmediately following the exercise intervention participants will consume their assigned maltodextrin supplement | Dietary supplement | Maltodextrin Placebo |
Primary outcome
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.
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.
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.
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.
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.
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.
Pro-Collagen Type I N-Propeptide (PINP)
Time frame: 1 hour prior to exercise
Osteoblastic marker of bone collagen synthesis
Pro-Collagen Type I N-Propeptide (PINP)
Time frame: 4 hours post exercise
Osteoblastic marker of bone collagen synthesis
5 secondary outcomes
Plasma Amino Acids Response to Supplementation
Time frame: 0 - 4 hours post-exercise
Muscle mechanistic target of rapamycin Pathway Activation
Time frame: 0 - 4 hours post-exercise
PCR Gene Expression of Muscle Collagen Genes (Types I, III, IV)
Time frame: 0 - 4 hours post-exercise
Pro-Collagen Type III N-Propeptide (PIIINP)
Time frame: 1 hour prior to exercise
Pro-Collagen Type III N-Propeptide (PIIINP)
Time frame: 4 hours post exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 27852613Shaw 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.
- Background: PubMed 27603578Holm 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.
- Background: PubMed 25294644Frontera 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.
- Background: PubMed 24237131Egerman 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.
- Background: PubMed 19903866Holm 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.
- Background: PubMed 31681789Alcock 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.
- Background: PubMed 16002437Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron Mitchell, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Amino Acid and Collagen Peptide in people with Skeletal Muscle and Extracellular Matrix, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional synthetic rate (change over time) of Myofibrillar Protein Synthesis (time frame: 0 - 4 hours post-exercise). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596553, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.