Developing a Nutritional Supplement to Increase Collagen Synthesis in People

Exercise Clinical Trial

Official title:

Developing a Nutritional Supplement to Increase Collagen Synthesis in People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138106
• Other study ID #: 2110494
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2023
• Source: University of California, Davis
• Contact: Kevin Paulussen, PhD
• Phone: 2177214479
• Email: kpaulussen[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Young healthy adults (18-30 y)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Connective Tissue
• Dietary Supplements
• Exercise

Intervention

Dietary Supplement:
• Natural 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.
• Placebo 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.

Locations

Country	Name	City	State
United States	Hickey Laboratory	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	AmpHP, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	7 days
Secondary	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.	60 minutes post-exercise
Secondary	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.	60 minutes post-exercise