ExosomesNCT05616234
Exercise-induced Changes in Exosomes
A study testing Resistance Exercise in people with Exosomes and Connective Tissue, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exosomes, Connective Tissue, Exercise
- What is being tested?
- Resistance Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young healthy adults (18-35 y)
- Experience with exercise (>1y)
Who cannot join
- Pregnancy
- Smoking
- Receiving any medication that may interfere with the study outcomes
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Exosomes, Connective Tissue, Exercise
- Being tested
- Resistance Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseProcedure or surgery
Participants will perform a bout of lower body resistance exercise consisting of leg press, leg extension and leg curls.
| Study group | Role | What they receive |
|---|---|---|
| Exercise trial | Experimental | Participants will perform a bout of exercise. In addition, a baseline and post-exercise blood sample will be drawn. Receives: Procedure: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 min post-exercise
Secondary outcomes (2)
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.
Measured: 15 min post-exercise
Exosomal RNA
Isolation and sequencing of exosomal RNA from serum obtained at baseline or post-exercise.
Measured: 15 min post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start7 Nov 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExosomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Baar, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616234
- Sponsor's protocol ID
- 1956959
- Status last verified
- Jun 2023
- First submitted
- 7 Nov 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced Changes in Exosomes
- ClinicalTrials.gov ID
- NCT05616234
- Acronym / sponsor ID
- 1956959
- Conditions
- Exosomes, Connective Tissue, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise trial | Experimental | Procedure: Resistance ExerciseParticipants will perform a bout of exercise. In addition, a baseline and post-exercise blood sample will be drawn. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Young healthy adults (18-35 y)
- Experience with exercise (>1y)
Key exclusion criteria (3 listed)
- Pregnancy
- Smoking
- Receiving any medication that may interfere with the study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseParticipants will perform a bout of lower body resistance exercise consisting of leg press, leg extension and leg curls. | Procedure or surgery | Exercise trial |
Primary outcome
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.
2 secondary outcomes
Ultimate tensile stress and modulus of ligament constructs
Time frame: 15 min post-exercise
Exosomal RNA
Time frame: 15 min post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Baar, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with Exosomes and Connective Tissue, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collagen content of ligament constructs (time frame: 15 min post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.