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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06054620
Other study ID # CVC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date August 1, 2025

Study information

Verified date November 2023
Source University of Toronto
Contact Daniel R Moore, PhD
Phone 416-946-4088
Email dr.moore@mail.utoronto
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date August 1, 2025
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Collagen and Vitamin C
Collagen-modelled crystalline amino acids (30g total, 8g glycine) and vitamin C (500 mg).
Carbohydrate Placebo
Iso-caloric Placebo (30g maltodextrin).

Locations

Country Name City State
Canada Goldring Centre for High Performance Sport at the University of Toronto Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. 24 hours
Primary 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 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. 9 hours
Secondary Concentration of Urinary Growth Hormone Urine will be collected overnight to measure growth hormone secretion using chemiluminescence. 8 hours
Secondary 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. 9 hours
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