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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Dietary Supplements; Connective Tissue
• Intervention / Treatment: Dietary supplement: Natural Product Supplement; Dietary supplement: Placebo control

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin Paulussen, PhD; Phone Number: 2177214479; Email: kpaulussen@ucdavis.edu
• Study Contact Backup: Name: Keith Baar, PhD

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Recruiting
      • Hickey Laboratory
      • Contact: Keith Baar, PhD; Email: kbaar@ucdavis.edu
      • Contact: Kevin Paulussen, PhD; Email: kpaulussen@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Young healthy adults (18-30 y)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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 Comparator: Placebo; The participant will consume a dose of hydrolyzed collagen (20g) supplemented with vitamin C (100 mg) and sweetener.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: AmpHP, Inc
• Investigators: Principal Investigator: Keith Baar, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2110494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No