- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616234
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
Conditions
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.
Sponsor
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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