Developing a Nutritional Supplement to Increase Collagen Synthesis in People

NCT ID: NCT06138106

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-21

Study Completion Date

2025-06-01

Brief Summary

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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

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Conditions

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Dietary Supplements Connective Tissue Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Natural Product Supplement

Intervention Type 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

The participant will consume a dose of hydrolyzed collagen (20g) supplemented with vitamin C (100 mg) and sweetener.

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Young healthy adults (18-30 y)

Exclusion Criteria

* Pregnancy
* Smoking
* Receiving any medication that may interfere with the study outcomes
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Baar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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Hickey Laboratory

Davis, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kevin Paulussen, PhD

Role: CONTACT

2177214479

Keith Baar, PhD

Role: CONTACT

Facility Contacts

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Kevin Paulussen, PhD

Role: primary

Keith Baar, PhD

Role: backup

Other Identifiers

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2110494

Identifier Type: -

Identifier Source: org_study_id

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