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

Interventional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054620
• Other study ID #: CVC
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Interventional

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