Developing a Nutritional Supplement to Increase Collagen Synthesis in People
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of California, Davis
About this trial
The purpose of this study is to test whether a natural product supplement can potentiate the increase in collagen synthesis following the ingestion of collagen protein. The investigators have developed a model of natural (GRAS certified) products that stimulate collagen synthesis, in vitro. The investigators will determine whether the natural product supplement can potentiate the collagen synthetic response to the ingestion of collagen protein. Basal and fed serum will be isolated and these samples will be used to treat human engineered ligaments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Young healthy adults (18-30 y)
Disqualifiers
Pregnancy
Smoking
Receiving any medication that may interfere with the study outcomes
Trial design
Design model
Crossover
Treatments tested in this trial
Natural Product Supplement
Dietary supplementParticipants will have blood drawn before and one hour after consuming the natural product supplement. For 7-days the participants will perform load-bearing exercise and consume the supplement. On the final day, blood will be collected 4 hours after the final exercise bout.
Placebo control
Dietary supplementParticipants will have blood drawn before and one hour after consuming the placebo supplement. For 7-days the participants will perform load-bearing exercise and consume the supplement. On the final day, blood will be collected 4 hours after the final exercise bout.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Natural Product SupplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Collagen protein synthesis
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 day 7 of the protocol).
Time frame
7 daysSecondary outcomes
1
Strength of ligament constructs
Serum from participants will be used to treat engineered ligaments in order to measure the effect of the supplementation on the strength of the ligaments. The strength will be measured using the Instron bio puls 68SC-1 tension and compression machine.
Time frame
60 minutes post-exercise2
Collagen content of ligament constructs
Ligament constructs will be treated for 7 days with experimental feed medium containing serum obtained at baseline or post-prandial for determination of collagen content using a hydroxyproline assay.
Time frame
60 minutes post-exerciseSponsors and contacts
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Source ClinicalTrials.gov