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Recruiting NCT06138106

Developing a Nutritional Supplement to Increase Collagen Synthesis in People

No phase Interventional Dietary Supplements Connective Tissue Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Natural Product Supplement, Placebo control.
Who it may be relevant to
Registry conditions: Dietary Supplements, Connective Tissue, Exercise. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Collagen protein synthesis [Time frame: 7 days]
Secondary outcome measures (2)
  • Strength of ligament constructs [Time frame: 60 minutes post-exercise]
  • Collagen content of ligament constructs [Time frame: 60 minutes post-exercise]

Eligibility criteria

Inclusion criteria

  • Young healthy adults (18-30 y)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hickey Laboratory — Davis

Identifiers

NCT: NCT06138106 · 2110494

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗