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

Sponsor
University of Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT06054620
Collaborator
(none)
12
1
2
22.5
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Collagen and Vitamin C
  • Dietary Supplement: Carbohydrate Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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-RESTCrossover 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
Masking:
None (Open Label)
Masking Description:
Double blinded (investigators and participants). A lab member external to the investigation will code items for the intervention.
Primary Purpose:
Basic Science
Official Title:
The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling
Actual Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Collagen and Vitamin C

Dietary Supplement: Collagen and Vitamin C
Collagen-modelled crystalline amino acids (30g total, 8g glycine) and vitamin C (500 mg).
Other Names:
  • CVC
  • Placebo Comparator: Carbohydrate Placebo

    Dietary Supplement: Carbohydrate Placebo
    Iso-caloric Placebo (30g maltodextrin).

    Outcome Measures

    Primary Outcome Measures

    1. Muscle Collagen Enrichment [9 hours]

      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.

    Secondary Outcome Measures

    1. Localization of Collagen Remodelling [9 hours]

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

    2. Urinary Growth Hormone [8 hours]

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

    3. Myofibrillar Protein Enrichment [9 hours]

      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.

    Other Outcome Measures

    1. Muscle Soreness [24 hours]

      Subjective muscle soreness will be quantified using a visual analog scale on trial day mornings and evenings as well as before and after exercise.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    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:
    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Goldring Centre for High Performance Sport at the University of Toronto Toronto Ontario Canada M5S 2C9

    Sponsors and Collaborators

    • University of Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Moore, Associate Professor, University of Toronto
    ClinicalTrials.gov Identifier:
    NCT06054620
    Other Study ID Numbers:
    • CVC
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Daniel Moore, Associate Professor, University of Toronto

    Study Results

    No Results Posted as of Sep 26, 2023