Effects of an Antioxidant Supplement on Blood Vessel Health
Part of paid clinical trials in Athens, Georgia.
- Sponsor
- University of Georgia
- Study ID
- NCT06424756
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- MitoQ — DIETARY_SUPPLEMENTMitoQ supplement is composed of mitoquinol mesylate, which is a synthetic analog of coenzyme Q10
- Placebo — DIETARY_SUPPLEMENTMitoQ matched Placebo
- MitoTempo — DRUGDuring 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.
- Tempol — DRUGDuring 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-NAME — DRUGDuring each experimental visit, L-NAME (nitric oxide synthase inhibitor) will be perfused through microdialysis fibers for quantification of nitric oxide-mediated vasodilation.
- SNP - Sodium Nitroprusside — DRUGAt the end of each experimental visit, SNP will be perfused through microdialysis fibers to elicit a maximal vasodilation response.
Study Details
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.
Key Dates
- Start date
- Jul 1, 2024
- Status verified
- Dec 2024
- Primary completion
- Mar 31, 2030
- Completion
- Mar 31, 2030
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: MitoQ, then PlaceboParticipants 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
- Experimental: Placebo, then MitoQParticipants 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
Primary Outcome Measure
Cutaneous microvascular responses to local heating [ Time Frame: 1 hour post intervention ]
Central Contacts
- S. Tony Wolf706-542-4378
- Melissa Gorejena
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ramsey Student Center, University of Georgia | Athens | Georgia | 30602 | - |
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