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NCT Number: NCT06138106

Developing a Nutritional Supplement to Increase Collagen Synthesis in People

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.

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Key information

Conditions

Dietary Supplements Behavior Connective Tissue Exercise Motor Activity

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hickey Laboratory

Davis, California, 95616, United States

Location status: Recruiting

Location contact

Keith Baar, PhD

CONTACT

[email protected]

Kevin Paulussen, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young healthy adults (18-30 y)

Exclusion criteria

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

Treatment and study plan

Natural Product Supplement

Dietary 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.

Placebo Control

Dietary Supplement

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.

Primary outcomes

  1. Collagen protein synthesis

    Time frame: 7 days

    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).

Secondary outcomes

  1. Strength of ligament constructs

    Time frame: 60 minutes post-exercise

    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.

  2. Collagen content of ligament constructs

    Time frame: 60 minutes post-exercise

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keith Baar, PhD

CONTACT

Kevin Paulussen, PhD

CONTACT

[email protected]

2177214479

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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