Clinical trial NCT06424756: Effects of an Antioxidant Supplement on Blood Vessel Health
Official title: Role of Mitochondria-derived Oxidative Stress on Microvascular Endothelial Function in Healthy Non-Hispanic Black and White Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Healthy
Keywords: Vascular dysfunction
Cardiovascular disease
Hypertension
Nitric oxide
Endothelial function
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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%.

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Cutaneous microvascular responses to local heating
timeFrame: 1 hour post intervention
measure: Flow-mediated dilation responses
timeFrame: 1 hour post intervention
measure: Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs)
timeFrame: 1 hour post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ramsey Student Center, University of Georgia
state: Georgia
Study officials:
References: