HealthyPhase 2NCT06424756
Effects of an Antioxidant Supplement on Blood Vessel Health
A Phase 2 study testing MitoQ, MitoTempo and Tempol in people with Healthy, run by University of Georgia at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide, and the non-Hispanic Black (NHB) population is disproportionately affected. Our research has previously demonstrated that oxidative stress may contribute to reduced vascular function in otherwise healthy NHB adults, potentially… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MitoQ, MitoTempo and Tempol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as either non-Hispanic Black or non-Hispanic White.
- Men and women 18-75 years old.
- Non-hypertensive (systolic blood pressure [SBP]<130 and diastolic blood pressure [DBP] <85 mmHg).
- Have low density lipoprotein cholesterol <150mg/dl.
- Have HbA1C <6.0%.
Who cannot join
- Rash, skin disease, or disorders of pigmentation (e.g., psoriasis, eczema, vitiligo, or other skin inflammatory skin disorders)
- Known skin allergies to latex or adhesives
- Smoking and/or use of nicotine-containing products within the past year
- Use of illegal/recreational drugs
- Generalized kidney disease
- Taking chloramphenicol, cholestyramine, medication for seizures, methotrexate, nitrofurantoin, tetracycline, barbiturates, steroids, phenobarbital/phenytoin, orlistat or pyrimethamine
Show all 12Show fewer
- Any current medications which could conceivably alter the cardiovascular control or responses
- Diagnosed or suspected metabolic or cardiovascular disease
- Current pregnancy or breastfeeding
- History of skin or other cancers
- Diagnosed or suspected diabetes (HbA1c ≥6.0)
- Anybody with narcolepsy or who has been diagnosed with any condition that impairs body temperature regulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melissa Gorejena contact
United States1 site, 1 recruiting
- Recruiting
Ramsey Student Center, University of Georgia
Athens, Georgia, 30602
About this study
Official title: Role of Mitochondria-derived Oxidative Stress on Microvascular Endothelial Function in Healthy Non-Hispanic Black and White Adults
Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide, and the non-Hispanic Black (NHB) population is disproportionately affected. Our research has previously demonstrated that oxidative stress may contribute to reduced vascular function in otherwise healthy NHB adults, potentially predisposing them to the development of hypertension and CVD. This study is designed to examine whether the mitochondria are an important source of oxidative stress-induced vascular dysfunction in healthy NHB adults.
- Conditions
- Healthy
- Being tested
- MitoQ, Placebo, MitoTempo, Tempol, L-NAME
- Keywords
- Vascular dysfunction, Cardiovascular disease, Hypertension, Nitric oxide, Endothelial function
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDietary supplement
MitoQ supplement is composed of mitoquinol mesylate, which is a synthetic analog of coenzyme Q10
PlaceboDietary supplement
MitoQ matched Placebo
MitoTempoDrug
During each experimental visit, intradermal microdialysis will be used to locally infuse MitoTempo (a mitochondria-specific superoxide dismutase mimetic) into the cutaneous microvasculature in the ventral aspect of the left forearm.
TempolDrug
During each experimental visit, intradermal microdialysis will be used to locally infuse Tempol (a superoxide dismutase mimetic) into the cutaneous microvasculature in the ventral aspect of the left forearm.
L-NAMEDrug
During each experimental visit, L-NAME (nitric oxide synthase inhibitor) will be perfused through microdialysis fibers for quantification of nitric oxide-mediated vasodilation.
SNP - Sodium NitroprussideDrug
At the end of each experimental visit, SNP will be perfused through microdialysis fibers to elicit a maximal vasodilation response.
| Study group | Role | What they receive |
|---|---|---|
| MitoQ, then Placebo | Experimental | Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days Receives: Dietary Supplement: MitoQ; Dietary Supplement: Placebo; Drug: MitoTempo; Drug: Tempol; Drug: L-NAME; Drug: SNP - Sodium Nitroprusside |
| Placebo, then MitoQ | Experimental | Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days Receives: Dietary Supplement: MitoQ; Dietary Supplement: Placebo; Drug: MitoTempo; Drug: Tempol; Drug: L-NAME; Drug: SNP - Sodium Nitroprusside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous microvascular responses to local heating
Using intradermal microdialysis, skin blood vessels will be locally treated with a mitochondria-targeted antioxidant (MitoTempo; 1 mM concentration). Nitric oxide (NO)-mediated skin vasodilation will be quantified via local inhibition of endothelial NO synthase during the course of the local skin heating protocol using L-NAME (15 mM concentration). Finally, maximal skin blood flow will be measured by heating the local area of skin to 43 degrees Celsius and locally perfusing sodium nitroprusside (SNP; an NO donor; 28 mM concentration). Two (2) thin fiber optic laser Doppler flowmeter probes and their holders, containing local heaters, will be used to measure skin blood flow.
Measured: 1 hour post intervention
Flow-mediated dilation responses
FMD measures the health of blood vessels. The ultrasound makes sound waves to measure the size of blood vessels and the speed of the blood during rest and occlusion. The cuff is inflated to 220 mmHg (a commonly-used suprasystolic pressure; i.e., arterial blood flow is completely occluded) for 5 minutes to stop blood flow to and from the forearm.
Measured: 1 hour post intervention
Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs)
Blood will be drawn for isolation of PBMCs and measurement of mitochondrial function and oxidative stress production.
Measured: 1 hour post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jul 2024
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For the experimental visits, participants will receive an antioxidant supplement in capsule form or a matching placebo pill in a randomized, double-blinded, crossover fashion. During each visit, participants will be given a single dose of the treatment to which they are randomized upon arrival at the laboratory (i.e., either 80 mg MitoQ or placebo will be administered on Visit 3, and the other treatment will be given on Visit 4). Peak concentrations of the antioxidant (MitoQ) occur after approximately 1 hour, allowing for appropriate time to prepare the participant for the experimental procedures.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S. Tony Wolf, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424756
- Sponsor's protocol ID
- PROJECT00009286
- Status last verified
- Dec 2024
- First submitted
- 16 May 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mitochondria-derived Oxidative Stress on Microvascular Endothelial Function in Healthy Non-Hispanic Black and White Adults
- ClinicalTrials.gov ID
- NCT06424756
- Acronym / sponsor ID
- PROJECT00009286
- Conditions
- Healthy
- Keywords
- Vascular dysfunction, Cardiovascular disease, Hypertension, Nitric oxide, Endothelial function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 22 May 2024 (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.
Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide, and the non-Hispanic Black (NHB) population is disproportionately affected. Our research has previously demonstrated that oxidative stress may contribute to reduced vascular function in otherwise healthy NHB adults, potentially predisposing them to the development of hypertension and CVD. This study is designed to examine whether the mitochondria are an important source of oxidative stress-induced vascular dysfunction in healthy NHB adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- For the experimental visits, participants will receive an antioxidant supplement in capsule form or a matching placebo pill in a randomized, double-blinded, crossover fashion. During each visit, participants will be given a single dose of the treatment to which they are randomized upon arrival at the laboratory (i.e., either 80 mg MitoQ or placebo will be administered on Visit 3, and the other treatment will be given on Visit 4). Peak concentrations of the antioxidant (MitoQ) occur after approximately 1 hour, allowing for appropriate time to prepare the participant for the experimental procedures.
| Arm | Type | Receives |
|---|---|---|
| MitoQ, then Placebo | Experimental | Dietary Supplement: MitoQ, Dietary Supplement: Placebo, Drug: MitoTempo, Drug: Tempol, Drug: L-NAME, Drug: SNP - Sodium NitroprussideParticipants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days |
| Placebo, then MitoQ | Experimental | Dietary Supplement: MitoQ, Dietary Supplement: Placebo, Drug: MitoTempo, Drug: Tempol, Drug: L-NAME, Drug: SNP - Sodium NitroprussideParticipants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identify as either non-Hispanic Black or non-Hispanic White.
- Men and women 18-75 years old.
- Non-hypertensive (systolic blood pressure [SBP]<130 and diastolic blood pressure [DBP] <85 mmHg).
- Have low density lipoprotein cholesterol <150mg/dl.
- Have HbA1C <6.0%.
Key exclusion criteria (12 listed)
- Rash, skin disease, or disorders of pigmentation (e.g., psoriasis, eczema, vitiligo, or other skin inflammatory skin disorders)
- Known skin allergies to latex or adhesives
- Smoking and/or use of nicotine-containing products within the past year
- Use of illegal/recreational drugs
- Generalized kidney disease
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 |
|---|---|---|
| MitoQMitoQ supplement is composed of mitoquinol mesylate, which is a synthetic analog of coenzyme Q10 | Dietary supplement | MitoQ, then Placebo, Placebo, then MitoQ |
| PlaceboMitoQ matched Placebo | Dietary supplement | MitoQ, then Placebo, Placebo, then MitoQ |
| MitoTempoDuring each experimental visit, intradermal microdialysis will be used to locally infuse MitoTempo (a mitochondria-specific superoxide dismutase mimetic) into the cutaneous microvasculature in the ventral aspect of the left forearm. | Drug | MitoQ, then Placebo, Placebo, then MitoQ |
| TempolDuring each experimental visit, intradermal microdialysis will be used to locally infuse Tempol (a superoxide dismutase mimetic) into the cutaneous microvasculature in the ventral aspect of the left forearm. | Drug | MitoQ, then Placebo, Placebo, then MitoQ |
| L-NAMEDuring each experimental visit, L-NAME (nitric oxide synthase inhibitor) will be perfused through microdialysis fibers for quantification of nitric oxide-mediated vasodilation. | Drug | MitoQ, then Placebo, Placebo, then MitoQ |
| SNP - Sodium NitroprussideAt the end of each experimental visit, SNP will be perfused through microdialysis fibers to elicit a maximal vasodilation response. | Drug | MitoQ, then Placebo, Placebo, then MitoQ |
Primary outcome
Cutaneous microvascular responses to local heating
Time frame: 1 hour post intervention
Using intradermal microdialysis, skin blood vessels will be locally treated with a mitochondria-targeted antioxidant (MitoTempo; 1 mM concentration). Nitric oxide (NO)-mediated skin vasodilation will be quantified via local inhibition of endothelial NO synthase during the course of the local skin heating protocol using L-NAME (15 mM concentration). Finally, maximal skin blood flow will be measured by heating the local area of skin to 43 degrees Celsius and locally perfusing sodium nitroprusside (SNP; an NO donor; 28 mM concentration). Two (2) thin fiber optic laser Doppler flowmeter probes and their holders, containing local heaters, will be used to measure skin blood flow.
Flow-mediated dilation responses
Time frame: 1 hour post intervention
FMD measures the health of blood vessels. The ultrasound makes sound waves to measure the size of blood vessels and the speed of the blood during rest and occlusion. The cuff is inflated to 220 mmHg (a commonly-used suprasystolic pressure; i.e., arterial blood flow is completely occluded) for 5 minutes to stop blood flow to and from the forearm.
Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs)
Time frame: 1 hour post intervention
Blood will be drawn for isolation of PBMCs and measurement of mitochondrial function and oxidative stress production.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
Melissa Gorejena contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MitoQ, MitoTempo and Tempol in people with Healthy, run by University of Georgia 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact S. Tony Wolf (706-542-4378, stwolf@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous microvascular responses to local heating (time frame: 1 hour post intervention). The study lists 3 primary outcomes in all. 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 Dec 2024.