Effects of an Antioxidant Supplement on Blood Vessel Health

University of Georgia (UGA)

Status and phase: Enrolling; Phase 2

Conditions: Healthy

Treatments: Drug: MitoTempo; Dietary Supplement: MitoQ; Drug: SNP - Sodium Nitroprusside; Drug: Tempol; Drug: L-NAME; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06424756

PROJECT00009286

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

MitoQ, then Placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo

Drug: L-NAME

Drug: SNP - Sodium Nitroprusside

Drug: Tempol

Drug: MitoTempo

Dietary Supplement: MitoQ

Placebo, then MitoQ

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo

Drug: L-NAME

Drug: SNP - Sodium Nitroprusside

Drug: Tempol

Drug: MitoTempo

Dietary Supplement: MitoQ