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Recruiting NCT06424756

Effects of an Antioxidant Supplement on Blood Vessel Health

Phase II Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MitoQ, Placebo, MitoTempo, Tempol.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Cutaneous microvascular responses to local heating [Time frame: 1 hour post intervention]
  • Flow-mediated dilation responses [Time frame: 1 hour post intervention]
  • Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs) [Time frame: 1 hour post intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Ramsey Student Center, University of Georgia — Athens

Identifiers

NCT: NCT06424756 · PROJECT00009286

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗