HealthyNCT05541133
Effect of Acute Exercise on Exosome Associated Biomarkers
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to understand the underlying mechanism by which exercise affects the body on the cellular level, in an acute aerobic endurance setting. This may help to better understand the overall benefits of endurance exercise. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 31 Dec 2024
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Generally healthy individuals around the Rochester MN area.
Who may be able to join
- Ages: 18 to 45 years
Who cannot join
- BMI >32 kg/m2. Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease.
- Orthopedic problems that would keep them from being able to perform an exercise. - --
- Medications that are known to affect mitochondrial function: Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta-blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist).
- Smoking.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This research study is being done to understand the underlying mechanism by which exercise affects the body on the cellular level, in an acute aerobic endurance setting. This may help to better understand the overall benefits of endurance exercise.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
List of biomarkers
Exosome proteomes and MiRNA from blood samples
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start21 Jun 2022
- Primary completion9 Jul 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. Sreekumaran Nair, Mayo Clinic
- Investigators
- K. Sreekumaran Nair, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541133
- Sponsor's protocol ID
- 22-000001
- Status last verified
- Apr 2025
- First submitted
- 12 Sep 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Exercise on Exosome Associated Biomarkers
- ClinicalTrials.gov ID
- NCT05541133
- Acronym / sponsor ID
- 22-000001
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Sep 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.
This research study is being done to understand the underlying mechanism by which exercise affects the body on the cellular level, in an acute aerobic endurance setting. This may help to better understand the overall benefits of endurance exercise.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Generally healthy individuals around the Rochester MN area.
Key inclusion criteria (1 listed)
- Ages: 18 to 45 years
Key exclusion criteria (5 listed)
- BMI >32 kg/m2. Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease.
- Orthopedic problems that would keep them from being able to perform an exercise. - --
- Medications that are known to affect mitochondrial function: Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta-blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist).
- Smoking.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
List of biomarkers
Time frame: Baseline
Exosome proteomes and MiRNA from blood samples
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 9 Apr 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
K. Sreekumaran Nair, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mayo Clinic 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 1 inclusion and 5 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 9 Apr 2025. 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?
List of biomarkers (time frame: Baseline). 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 9 Apr 2025.