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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05616234
Other study ID # 1956959
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date February 17, 2023

Study information

Verified date June 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study aims to shed light on the function/importance/relevance of exercise-induced changes in exosomes to connective tissues. Exosomes are known to increase robustly in response to exercise. We have previously shown that serum isolated from subjects after they lift heavy weights increases human engineered ligament collagen content and mechanics more than serum from before they lift weight. Further, we showed that exercise-induced changes in hormones could not explain the change in ligament structure or function. These data indicate that there is a significant gap in our understanding of muscle-connective tissue crosstalk. To address this gap, the current proposal seeks to: i) isolate and sequence exosomal RNA (long non-coding, miR, and mRNA) and ii) determine whether exosomes isolated from serum after exercise increase engineered ligament mechanics and collagen content.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date February 17, 2023
Est. primary completion date February 17, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Young healthy adults (18-35 y) - Experience with exercise (>1y) Exclusion Criteria: - Pregnancy - Smoking - Receiving any medication that may interfere with the study outcomes

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Resistance Exercise
Participants will perform a bout of lower body resistance exercise consisting of leg press, leg extension and leg curls.

Locations

Country Name City State
United States Hickey Laboratory Davis California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Collagen content of ligament constructs Ligament constructs will be treated for 7 days with experimental feed medium containing serum, or exosomes isolated from serum, obtained at baseline or post-exercise for determination of collagen content using a hydroxyproline assay. 15 min post-exercise
Secondary Ultimate tensile stress and modulus of ligament constructs ligament constructs will be treated for 7 days with experimental feed medium containing serum, or exosomes isolated from serum, obtained at baseline or post-exercise for determination of ultimate tensile stress and modulus. 15 min post-exercise
Secondary Exosomal RNA Isolation and sequencing of exosomal RNA from serum obtained at baseline or post-exercise. 15 min post-exercise
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