Effects of Vitamin C Enriched Hydrolyzed Collagen, PrimaColl™, Whey Protein, or Placebo on Collagen Synthesis
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| ClinicalTrials.gov Identifier: NCT05427279 |
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Recruitment Status :
Recruiting
First Posted : June 22, 2022
Last Update Posted : December 19, 2022
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| Tracking Information | |||||||||
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| First Submitted Date ICMJE | June 9, 2022 | ||||||||
| First Posted Date ICMJE | June 22, 2022 | ||||||||
| Last Update Posted Date | December 19, 2022 | ||||||||
| Actual Study Start Date ICMJE | October 5, 2022 | ||||||||
| Estimated Primary Completion Date | June 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Collagen protein synthesis [ Time Frame: Baseline (0 hour) to 4 hours after last exercise bout (at 28 hour of the protocol) ] Collagen protein synthesis will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4 hours after the last exercise bout (at 28 hours of the protocol)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Vitamin C Enriched Hydrolyzed Collagen, PrimaColl™, Whey Protein, or Placebo on Collagen Synthesis | ||||||||
| Official Title ICMJE | Investigating the Effects of 24-hours of Repeated Doses of Vitamin C Enriched Hydrolyzed Collagen, PrimaColl™, Whey Protein, or Placebo on Collagen Synthesis | ||||||||
| Brief Summary | The purpose of this study is to determine the effects of repeated dosing vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis. To achieve this, participants will consume a supplemental dose of HC (20g with 50mg vitamin C), PC (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to an exercise bout (6 minutes of jump rope), this will be repeated three times over a 24h period. The amount of collagen protein synthesized will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4hrs after the last exercise bout. |
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| Detailed Description | The purpose of this study is to determine the effects of repeated dosing of vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis. To achieve this, participants will consume a supplemental dose of HC (20g with 50mg vitamin C), PC (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to exercise bouts (6 minutes of jump rope). The amount of collagen protein synthesized will be indirectly measured by measuring procollagen type I N-terminal propeptide (PINP) in the serum before and 4hrs after the last exercise bout. It is expected that this project will determine whether greater increases in collagen synthesis are observed with repeated doses of HC and exercise, compared with a single dose and exercise bout (from previous research). This study will also determine whether collagen synthesis is similarly stimulated with PrimaColl, or whey protein. Results from this study will help to better prescribe the use of dietary collagen and exercise training to improve collagen synthesis in healthy young people. Improved collagen synthesis has the potential to decrease ligament, tendon, and bone injuries in the general and athletic populations. Male and female participants between the ages of 18-30 years of age will be enrolled in the study. A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment (HC, PC, WP or PL). I. Baseline blood draw The subjects will arrive in the laboratory following an overnight fast. The antecubital vein will be cannulated, and an initial 5 mL baseline blood sample will be collected. II. Supplementation After baseline blood draw subjects will be provided with a supplement as shown in the table below. Subjects will be asked to consume the supplement that will be pre-mixed with 250 ml of water 60 min before the jump rope exercise. This will be repeated 3 times, separated by 12 hours over a 24h period. III. Exercise Sixty minutes after the ingestion of the supplement, each participant will complete 6 minutes of jump rope. This will be repeated on 3 occasions over a 24hr period. Subjects will be asked to abstain from vigorous exercise during the 24hr period, aside from the prescribed jump rope exercise. Subjects will be asked to ingest supplement and jump rope in lab for time point 1. Subjects will be given the option to ingest supplement and jump rope outside lab if more conducive to their scheduling restrictions at time points 2 and 3 blood draws are not required at these timepoints. Subjects will be asked to return to the lab 4 hours after last jumping session for blood sampling. Blood draws for PNIP analysis Blood samples (5 mL) at different time points:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Participants will consume a supplemental dose of hydrolyzed collagen (20g with 50mg vitamin C), PrimaColl (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to exercise bouts (6 minutes of jump rope). The type of consumed supplementation will be randomized where neither the participant nor investigator will know which supplement is being consumed. Each participant will repeat the protocol four times. Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment. The interventions will be coded using a blinded alphabetical letter code (A, B, C, D). A delegate researcher (independent party not further involved in the study) will randomize all interventions using a computer-generated randomization list. The delegate will hand in the code-breaker to the principal investigator in a sealed envelope. The envelope will be stored in a locked filing cabinet in the principal investigator's office, which will also be locked when unoccupied. The envelope will be opened by the principal investigator after completing the analysis of blood samples. Primary Purpose: Other
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| Condition ICMJE | Effect of Food Supplement | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | June 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 30 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT05427279 | ||||||||
| Other Study ID Numbers ICMJE | 220518 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Current Responsible Party | University of California, Davis | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | University of California, Davis | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | Geltor | ||||||||
| Investigators ICMJE |
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| PRS Account | University of California, Davis | ||||||||
| Verification Date | December 2022 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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