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Developing a Nutritional Supplement to Increase Collagen Synthesis in People

Developing a Nutritional Supplement to Increase Collagen Synthesis in People

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06138106
Enrollment
20
Registered
2023-11-18
Start date
2023-11-21
Completion date
2026-12-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Connective Tissue, Dietary Supplements, Exercise

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTNatural Product Supplement

Participants 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.

DIETARY_SUPPLEMENTPlacebo control

Participants 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.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Young healthy adults (18-30 y)

Exclusion criteria

* Pregnancy * Smoking * Receiving any medication that may interfere with the study outcomes

Design outcomes

Primary

MeasureTime frameDescription
Collagen protein synthesis7 daysCollagen 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).

Secondary

MeasureTime frameDescription
Strength of ligament constructs60 minutes post-exerciseSerum 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.
Collagen content of ligament constructs60 minutes post-exerciseLigament 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.

Countries

United States

Contacts

CONTACTKevin Paulussen, PhD
kpaulussen@ucdavis.edu2177214479
CONTACTKeith Baar, PhD
PRINCIPAL_INVESTIGATORKeith Baar, PhD

University of California, Davis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026