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RecruitingNCT06054620Updated Nov 13, 2023

The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling

An interventional study of Collagen and Vitamin C and Carbohydrate Placebo in Interventional, sponsored by University of Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by University of Toronto · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Interventional

Keywords

  • Collagen
  • Vitamin C
  • Carbohydrate placebo
03

In context

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Active comparator
    Collagen and Vitamin C

    Dietary Supplement: Collagen and Vitamin C

  • Placebo comparator
    Carbohydrate Placebo

    Dietary Supplement: Carbohydrate Placebo

Interventions

  • Dietary supplementCollagen and Vitamin C

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

    Also known as: CVC

  • Dietary supplementCarbohydrate Placebo

    Iso-caloric Placebo (30g maltodextrin).

06

What researchers measure

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.

    Time frame: 9 hours

Secondary outcomes

  1. Area of muscle with localized collagen remodelling

    Immunofluorescence determined localization of collagen breakdown and synthesis using collagen hybridizing peptide and procollagen antibodies, respectively, on human skeletal muscle cross-sections.

    Time frame: 9 hours

  2. Concentration of Urinary Growth Hormone

    Urine will be collected overnight to measure growth hormone secretion using chemiluminescence.

    Time frame: 8 hours

  3. Enrichment of Myofibrillar Protein

    Overnight incorporation of orally ingested amino acid tracer (D5 Gly and D5 Phe) into myofibrillar proteins 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.

    Time frame: 9 hours

Other outcomes

  1. Intensity of Muscle Soreness

    Subjective muscle soreness will be quantified using a visual analog scale on trial day mornings and evenings as well as before and after exercise. Using a line spanning 0 to 100 (100 being greatest soreness), participants will select a spot on the line indicating their subjective muscle soreness.

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06054620
Lead sponsor
University of Toronto
Responsible party
Daniel Moore (Associate Professor, University of Toronto) — Principal investigator
First posted
Sep 26, 2023
Start date
Sep 15, 2023
Primary completion
Sep 1, 2024 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Nov 13, 2023

Study contacts

Daniel R Moore, PhD
Contact
dr.moore@mail.utoronto
416-946-4088
Paul L Babits, BKin
Contact
paul.babits@mail.utoronto.ca
647-609-4710

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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