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

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.

Study Overview

• Status: Recruiting
• Conditions: Interventional
• Intervention / Treatment: Dietary supplement: Collagen and Vitamin C; Dietary supplement: Carbohydrate Placebo

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel R Moore, PhD; Phone Number: 416-946-4088; Email: dr.moore@mail.utoronto
• Study Contact Backup: Name: Paul L Babits, BKin; Phone Number: 647-609-4710; Email: paul.babits@mail.utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 2C9
      • Recruiting
      • Goldring Centre for High Performance Sport at the University of Toronto
      • Contact: Dan R Moore, PhD; Phone Number: 647-946-4088; Email: dr.moore@mail.utoronto.ca
      • Contact: Paul L Babits, BKin; Email: paul.babits@mail.utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Carbohydrate Placebo	Dietary supplement: Carbohydrate Placebo; Iso-caloric Placebo (30g maltodextrin).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Collagen Enrichment	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localization of Collagen Remodelling	Immunofluorescence determined localization of collagen breakdown and synthesis using collagen hybridizing peptide and procollagen antibodies, respectively, on human skeletal muscle cross-sections.	9 hours
Urinary Growth Hormone	Urine will be collected overnight to measure growth hormone secretion using chemiluminescence.	8 hours
Myofibrillar Protein Enrichment	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.	9 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin C; Collagen; Carbohydrate placebo
• Other Study ID Numbers: CVC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No