Developing a Nutritional Supplement to Increase Collagen Synthesis in People

Not Applicable

Recruiting

• Conditions: Connective Tissue; Dietary Supplements; Exercise
• Interventions: Dietary Supplement: Natural Product Supplement; Dietary Supplement: Placebo control

• Registration Number: NCT06138106
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Study Start: 2023-11-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Young healthy adults (18-30 y)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Natural Product Supplement	Natural Product Supplement	The participant will consume a dose of hydrolyzed collagen (20g) supplemented with vitamin C (100 mg), epicatechin (75 mg), vitamin E (350 iU) and stevia extract (225 mg).
Placebo	Placebo control	The participant will consume a dose of hydrolyzed collagen (20g) supplemented with vitamin C (100 mg) and sweetener.

Primary Outcome Measures

Name	Time	Method
Collagen protein synthesis	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 Outcome Measures

Name	Time	Method
Strength of ligament constructs	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.
Collagen content of ligament constructs	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.

Trial Locations

Locations (1)

Hickey Laboratory; 🇺🇸 Davis, California, United States