NCT06424756

Effects of an Antioxidant Supplement on Blood Vessel Health

Role of Mitochondria-derived Oxidative Stress on Microvascular Endothelial Function in Healthy Non-Hispanic Black and White Adults

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Georgia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MitoQ	MitoQ supplement is composed of mitoquinol mesylate, which is a synthetic analog of coenzyme Q10
DIETARY_SUPPLEMENT	Placebo	MitoQ matched Placebo
DRUG	MitoTempo	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.
DRUG	Tempol	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.
DRUG	L-NAME	During each experimental visit, L-NAME (nitric oxide synthase inhibitor) will be perfused through microdialysis fibers for quantification of nitric oxide-mediated vasodilation.
DRUG	SNP - Sodium Nitroprusside	At the end of each experimental visit, SNP will be perfused through microdialysis fibers to elicit a maximal vasodilation response.

Timeline

• Start date: 2024-07-01
• Primary completion: 2030-03-31
• Completion: 2030-03-31
• First posted: 2024-05-22
• Last updated: 2024-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study