Developing a Nutritional Supplement to Increase Collagen Synthesis in People

Sponsor

University of California, Davis (Other)

Overall Status

Recruiting

CT.gov ID

NCT06138106

Collaborator

AmpHP, Inc (Other)

Enrollment

Location

Arms

3.7

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary Supplements Connective Tissue Exercise	Dietary Supplement: Natural Product Supplement Dietary Supplement: Placebo control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Developing a Nutritional Supplement to Increase Collagen Synthesis in People

Anticipated Study Start Date :

Nov 8, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Young healthy adults (18-35 y)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hickey Laboratory	Davis	California	United States	95616

Sponsors and Collaborators

University of California, Davis
AmpHP, Inc

Investigators

Principal Investigator: Keith Baar, PhD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT06138106

Other Study ID Numbers:

2110494-2

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 18, 2023