NCT04596553

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2022

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

September 28, 2020

Last Update Submit

June 9, 2023

Conditions

Keywords

Muscle Collagen TurnoverMyofibrillar Protein SynthesisExtracellular MatrixAnabolism SignalingResistance ExerciseSkeletal MuscleBone Turnover

Outcome Measures

Primary Outcomes (8)

  • Fractional synthetic rate (change over time) of Myofibrillar Protein Synthesis

    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

    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

    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

    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

    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

    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)

    Osteoblastic marker of bone collagen synthesis

    1 hour prior to exercise

  • Pro-Collagen Type I N-Propeptide (PINP)

    Osteoblastic marker of bone collagen synthesis

    4 hours post exercise

Secondary Outcomes (5)

  • Plasma Amino Acids Response to Supplementation

    0 - 4 hours post-exercise

  • Muscle mechanistic target of rapamycin Pathway Activation

    0 - 4 hours post-exercise

  • PCR Gene Expression of Muscle Collagen Genes (Types I, III, IV)

    0 - 4 hours post-exercise

  • Pro-Collagen Type III N-Propeptide (PIIINP)

    1 hour prior to exercise

  • Pro-Collagen Type III N-Propeptide (PIIINP)

    4 hours post exercise

Study Arms (3)

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

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

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

Dietary Supplement: Maltodextrin Placebo

Interventions

Essential Amino AcidDIETARY_SUPPLEMENT

Immediately following the exercise intervention participants will consume their assigned essential amino acid supplement

Essential Amino Acid
Collagen PeptideDIETARY_SUPPLEMENT

Immediately following the exercise intervention participants will consume their assigned collagen peptide supplement

Collagen Peptide
Maltodextrin PlaceboDIETARY_SUPPLEMENT

Immediately following the exercise intervention participants will consume their assigned maltodextrin supplement

Maltodextrin Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Can fluently read and write in English
  • Male
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chan Gunn Pavilion

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (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.

    PMID: 27852613BACKGROUND
  • 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.

    PMID: 27603578BACKGROUND
  • 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.

    PMID: 25294644BACKGROUND
  • 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.

    PMID: 24237131BACKGROUND
  • 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.

    PMID: 19903866BACKGROUND
  • 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.

    PMID: 31681789BACKGROUND
  • 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.

    PMID: 16002437BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Amino Acids, Essential

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Cameron Mitchell, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: \- Double-blinded, randomized controlled, parallel design study, with 3 treatment groups (placebo, collagen peptide, and essential amino acid)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 22, 2020

Study Start

January 25, 2021

Primary Completion

February 13, 2022

Study Completion

February 13, 2022

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations