AgingNCT05872139
Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging
A study testing Mitoquinone Mesylate in people with Aging and Endothelial Dysfunction, run by Ball State University at 1 site in United States.
Trial summary
The primary goal of this intervention is to determine the efficacy of acute mitochondrial-specific antioxidants to improve vascular endothelial function in middle-aged and older (≥45 y) adults who do no perform regular aerobic exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Endothelial Dysfunction, Cardiovascular Function
- What is being tested?
- Mitoquinone Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 1 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resting brachial blood pressure <160 mmHg (systolic)/<100 mmHg (diastolic)
- Body mass index ≤ 35 kg/m2
- Nonsmoker
- Women must be postmenopausal defined as cessation of menses ≥ 1 year.
Who cannot join
- cardiovascular/metabolic medications
- known clinical disease
- absolute contraindications to exercise testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Exercise/Cardiorespiratory Fitness on Enhanced Endothelial Function With Aging: Role of Mitochondrial-derived Oxidative Stress
The primary goal of this intervention is to determine the efficacy of acute mitochondrial-specific antioxidants to improve vascular endothelial function in middle-aged and older (≥45 y) adults who do no perform regular aerobic exercise. In a double-blind, randomized, placebo-controlled crossover design participants with receive both MitoQ and placebo arm of the study. Primary endpoints will include vascular endothelial function assessed by brachial artery flow-mediated dilation and cardiac function assessed via pulse wave analysis. Secondary endpoints will include measures of aortic stiffness assessed by carotid-femoral pulse wave velocity and carotid artery stiffness (e.g. β-stiffness) and elasticity (carotid compliance, distensibility, and Youngs elastic modulus) from ultrasonography.
- Being tested
- Placebo, Mitoquinone Mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Gelatin capsules
Mitoquinone MesylateDietary supplement
Also called MitoQ
MitoQ was given once (single dose, 80 mg)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Gelatin capsules Receives: Dietary Supplement: Placebo |
| MitoQ | Experimental | Capsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 80 mg were taken once. Receives: Dietary Supplement: Mitoquinone Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular endothelial function
Brachial artery flow-mediated dilation (% [relative] and mm [absolute])
Measured: Baseline and Post 1 hour
Secondary outcomes (6)
Change in cardiovascular function
Subendocardial viability ratio (%)
Measured: Baseline and Post 1 hour
Change in Aortic Stiffness
Carotid-femoral pulse wave velocity (meters/second)
Measured: Baseline and Post 1 hour
Change in carotid artery stiffness - beta-stiffness index
Carotid artery Beta stiffness index (AU)
Measured: Baseline and Post 1 hour
Change in carotid artery compliance
Carotid artery compliance (mmHg/mm^2)
Measured: Baseline and Post 1 hour
Change in carotid artery distensibility
Carotid artery distensibility (10^-3/kilopascals)
Measured: Baseline and Post 1 hour
Change in carotid artery Young's elastic modulus
Carotid artery Young's elastic modulus (kilopascals, kPa)
Measured: Baseline and Post 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start23 Sep 2022
- Primary completion17 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Fleenor, Ball State University
- Investigators
- Brad Fleenor, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872139
- Sponsor's protocol ID
- MitoQ
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlini NA, Harber MP, Fleenor BS. Acute effects of MitoQ on vascular endothelial function are influenced by cardiorespiratory fitness and baseline FMD in middle-aged and older adults. J Physiol. 2024 May;602(9):1923-1937. doi: 10.1113/JP285636. Epub 2024 Apr 3.
PubMed 38568933
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Exercise/Cardiorespiratory Fitness on Enhanced Endothelial Function With Aging: Role of Mitochondrial-derived Oxidative Stress
- ClinicalTrials.gov ID
- NCT05872139
- Acronym / sponsor ID
- MitoQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 24 May 2023 (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 primary goal of this intervention is to determine the efficacy of acute mitochondrial-specific antioxidants to improve vascular endothelial function in middle-aged and older (≥45 y) adults who do no perform regular aerobic exercise. In a double-blind, randomized, placebo-controlled crossover design participants with receive both MitoQ and placebo arm of the study. Primary endpoints will include vascular endothelial function assessed by brachial artery flow-mediated dilation and cardiac function assessed via pulse wave analysis. Secondary endpoints will include measures of aortic stiffness assessed by carotid-femoral pulse wave velocity and carotid artery stiffness (e.g. β-stiffness) and elasticity (carotid compliance, distensibility, and Youngs elastic modulus) from ultrasonography.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboGelatin capsules |
| MitoQ | Experimental | Dietary Supplement: Mitoquinone MesylateCapsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 80 mg were taken once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resting brachial blood pressure <160 mmHg (systolic)/<100 mmHg (diastolic)
- Body mass index ≤ 35 kg/m2
- Nonsmoker
- Women must be postmenopausal defined as cessation of menses ≥ 1 year.
Key exclusion criteria (3 listed)
- cardiovascular/metabolic medications
- known clinical disease
- absolute contraindications to exercise testing
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 |
|---|---|---|
| PlaceboGelatin capsules | Dietary supplement | Placebo |
| Mitoquinone MesylateAlso: MitoQMitoQ was given once (single dose, 80 mg) | Dietary supplement | MitoQ |
Primary outcome
Change in vascular endothelial function
Time frame: Baseline and Post 1 hour
Brachial artery flow-mediated dilation (% [relative] and mm [absolute])
6 secondary outcomes
Change in cardiovascular function
Time frame: Baseline and Post 1 hour
Change in Aortic Stiffness
Time frame: Baseline and Post 1 hour
Change in carotid artery stiffness - beta-stiffness index
Time frame: Baseline and Post 1 hour
Change in carotid artery compliance
Time frame: Baseline and Post 1 hour
Change in carotid artery distensibility
Time frame: Baseline and Post 1 hour
Change in carotid artery Young's elastic modulus
Time frame: Baseline and Post 1 hour
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 24 May 2023.
- Derived from this study: PubMed 38568933Carlini NA, Harber MP, Fleenor BS. Acute effects of MitoQ on vascular endothelial function are influenced by cardiorespiratory fitness and baseline FMD in middle-aged and older adults. J Physiol. 2024 May;602(9):1923-1937. doi: 10.1113/JP285636. Epub 2024 Apr 3.
- 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.
Brad Fleenor, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitoquinone Mesylate in people with Aging and Endothelial Dysfunction, run by Ball State University 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 4 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 24 May 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. Some participants in this study may receive a placebo. 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?
Change in vascular endothelial function (time frame: Baseline and Post 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05872139, which also lists 1 linked publication.
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 24 May 2023.