Exercise-induced Changes in Exosomes

June 13, 2023 updated by: University of California, Davis
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Davis, California, United States, 95616
        • Hickey Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise trial
Participants will perform a bout of exercise. In addition, a baseline and post-exercise blood sample will be drawn.
Participants will perform a bout of lower body resistance exercise consisting of leg press, leg extension and leg curls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collagen content of ligament constructs
Time Frame: 15 min post-exercise
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultimate tensile stress and modulus of ligament constructs
Time Frame: 15 min post-exercise
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
Exosomal RNA
Time Frame: 15 min post-exercise
Isolation and sequencing of exosomal RNA from serum obtained at baseline or post-exercise.
15 min post-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2022

Primary Completion (Actual)

February 17, 2023

Study Completion (Actual)

February 17, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1956959

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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