NCT06054620

Brief Summary

The primary objective of this study will be to determine the influence of a presleep vitamin C-enriched, collagen-modelled supplement (CVC) on the metabolic fate of dietary glycine using a \[2H5\]glycine tracer within the intramuscular connective tissue at rest and after a bout of resistance exercise. Other outcomes will be related to regulation collagen remodelling in skeletal muscle.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

September 19, 2023

Last Update Submit

November 8, 2023

Conditions

Keywords

CollagenVitamin CCarbohydrate placebo

Outcome Measures

Primary Outcomes (1)

  • Enrichment of Muscle Collagen

    Overnight incorporation of orally ingested amino acid tracer (D5 Gly and D5 Phe) into mature collagen protein isolated from skeletal muscle biopsy samples taken 9 hours after consumption of the tracer-containing supplement (CVC or PLA) and rest or resistance exercise. Enrichment will be quantified via tandem LC-MS/MS.

    9 hours

Secondary Outcomes (3)

  • Area of muscle with localized collagen remodelling

    9 hours

  • Concentration of Urinary Growth Hormone

    8 hours

  • Enrichment of Myofibrillar Protein

    9 hours

Other Outcomes (1)

  • Intensity of Muscle Soreness

    24 hours

Study Arms (2)

Collagen and Vitamin C

ACTIVE COMPARATOR
Dietary Supplement: Collagen and Vitamin C

Carbohydrate Placebo

PLACEBO COMPARATOR
Dietary Supplement: Carbohydrate Placebo

Interventions

Collagen and Vitamin CDIETARY_SUPPLEMENT

Collagen-modelled crystalline amino acids (30g total, 8g glycine) and vitamin C (500 mg).

Also known as: CVC
Collagen and Vitamin C
Carbohydrate PlaceboDIETARY_SUPPLEMENT

Iso-caloric Placebo (30g maltodextrin).

Carbohydrate Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy, recreationally active, male and female participants.
  • Healthy will be defined as someone who does not have a health condition that would compromise their ability to safely participate in the strenuous physical activity involved in our study as screened for by the Get Active Questionnaire.
  • Willing to abstain from resistance exercise for 2 weeks prior to the first metabolic trial and for the duration of the study.
  • Participants must be able to abstain from lower-body resistance and/or plyometric exercise for at least 2 weeks prior to the first metabolic trial.
  • Participants will be aged 18-35 years old.
  • Participants must be normal to overweight (e.g., BMI 18.5-30).
  • Participants are willing to abide by the compliance rules of this study (e.g., abstain from physical activity and alcohol 48h prior to each trial).
  • Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).

You may not qualify if:

  • Inability to adhere to any of the compliance rules judged by principal investigator or medical doctor.
  • Self-reported regular tobacco use.
  • Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.).
  • Regular use of anti-inflammatory drugs (e.g., ibuprofen).
  • Self-reported regularly sleeping less than an average of 7 hours over 3 days (minimum recommended daily amount).
  • Individuals who have participated in studies within the past year involving any of the stable isotopes in the study.
  • Use of birth control and discontinued use in the last 3-months (female only).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport at the University of Toronto

Toronto, Ontario, M5S 2C9, Canada

RECRUITING

MeSH Terms

Interventions

CollagenAscorbic Acid

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and ProteinsSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Central Study Contacts

Daniel R Moore, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Double blinded (investigators and participants). A lab member external to the investigation will code items for the intervention.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover to receive Collagen and Vitamin C (CVC) or Carbohydrate placebo. Unilateral leg exercise (EX) to give 4 outcomes. (1) CVC-EX; (2) CVC-REST; (3) PLACEBO-EX; (4) PLACEBO-REST
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

September 15, 2023

Primary Completion

September 1, 2024

Study Completion

August 1, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations