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NCT Number: NCT06424756

Effects of an Antioxidant Supplement on Blood Vessel Health

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.

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Key information

Conditions

Healthy Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ramsey Student Center, University of Georgia

Athens, Georgia, 30602, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MitoQ

Dietary Supplement

MitoQ supplement is composed of mitoquinol mesylate, which is a synthetic analog of coenzyme Q10

Placebo

Dietary Supplement

MitoQ matched Placebo

MitoTempo

Drug

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.

Tempol

Drug

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-NAME

Drug

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 Nitroprusside

Drug

At the end of each experimental visit, SNP will be perfused through microdialysis fibers to elicit a maximal vasodilation response.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Gorejena

CONTACT

[email protected]

S. Tony Wolf

CONTACT

[email protected]

706-542-4378

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
May 22, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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