InterventionalNCT06054620
The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling
A study testing Collagen and Vitamin C in people with Interventional, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Interventional
- What is being tested?
- Collagen and Vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, M5S 2C9
Dan R Moore, PhD, 647-946-4088, dr.moore@mail.utoronto.ca
Paul L Babits, BKin, paul.babits@mail.utoronto.ca
About this study
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.
- Conditions
- Interventional
- Being tested
- Collagen and Vitamin C, Carbohydrate Placebo
- Keywords
- Collagen, Vitamin C, Carbohydrate placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen and Vitamin CDietary supplement
Also called CVC
Collagen-modelled crystalline amino acids (30g total, 8g glycine) and vitamin C (500 mg).
Carbohydrate PlaceboDietary supplement
Iso-caloric Placebo (30g maltodextrin).
| Study group | Role | What they receive |
|---|---|---|
| Collagen and Vitamin C | Active comparator | Not described Receives: Dietary Supplement: Collagen and Vitamin C |
| Carbohydrate Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Carbohydrate Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 hours
Secondary outcomes (3)
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.
Measured: 9 hours
Concentration of Urinary Growth Hormone
Urine will be collected overnight to measure growth hormone secretion using chemiluminescence.
Measured: 8 hours
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.
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start15 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionalStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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-REST
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054620
- Sponsor's protocol ID
- CVC
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling
- ClinicalTrials.gov ID
- NCT06054620
- Acronym / sponsor ID
- CVC
- Conditions
- Interventional
- Keywords
- Collagen, Vitamin C, Carbohydrate placebo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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-REST
| Arm | Type | Receives |
|---|---|---|
| Collagen and Vitamin C | Active comparator | Dietary Supplement: Collagen and Vitamin C |
| Carbohydrate Placebo | Placebo comparator | Dietary Supplement: Carbohydrate Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen and Vitamin CAlso: CVCCollagen-modelled crystalline amino acids (30g total, 8g glycine) and vitamin C (500 mg). | Dietary supplement | Collagen and Vitamin C |
| Carbohydrate PlaceboIso-caloric Placebo (30g maltodextrin). | Dietary supplement | Carbohydrate Placebo |
Primary outcome
Enrichment of Muscle Collagen
Time frame: 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.
3 secondary outcomes
Area of muscle with localized collagen remodelling
Time frame: 9 hours
Concentration of Urinary Growth Hormone
Time frame: 8 hours
Enrichment of Myofibrillar Protein
Time frame: 9 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen and Vitamin C in people with Interventional, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel R Moore, PhD (416-946-4088, dr.moore@mail.utoronto), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrichment of Muscle Collagen (time frame: 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.