Study on Antioxidant Supplements and Blood Vessel Health in Healthy Adults

This study is looking at how antioxidant supplements affect blood vessel health in healthy adults, especially those who are non-Hispanic Black. Researchers are testing a supplement called MitoQ, a placebo (an inactive substance that looks like the real thing), and two drugs called MitoTempo and Tempol. They will also use L-NAME, which helps measure how blood vessels widen. The goal is to see if mitochondria (parts of your cells that produce energy) are involved in problems with blood vessel function. To join, you should be between 18 and 75 years old, identify as non-Hispanic Black or non-Hispanic White, and have healthy blood pressure and cholesterol levels. The study will measure how your blood vessels respond to heat, how well they widen, and mitochondrial activity in your blood cells.

Study design
This is an interventional study planning to enroll 60 healthy participants. It tests different dietary supplements and drugs to understand their effects.
What's involved
During each experimental visit, you will have MitoTempo, Tempol, or L-NAME infused into your forearm using a microdialysis technique. Blood vessel responses and blood cell activity will be measured.
Compensation
Not stated in the trial record.
Follow-up
Primary endpoints are measured at 1 hour post intervention.

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NCT06424756

Effects of an Antioxidant Supplement on Blood Vessel Health

Recruiting
PHASE2Ages 18–75InterventionalTreatment
University of Georgia
~60 participants
Updated 2024-12-09 on ClinicalTrials.gov
What's tested:MitoQPlaceboMitoTempoTempolL-NAMESNP - Sodium Nitroprusside

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cutaneous microvascular responses to local heating
Measured over 1 hour post intervention
+2 more outcomes measured
Healthy
1 sites across 1 states
Georgia1

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Eligibility criteria

Inclusion

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

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.
  • Cutaneous microvascular responses to local heating1 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.

  • Flow-mediated dilation responses1 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.

  • Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs)1 hour post intervention

    Blood will be drawn for isolation of PBMCs and measurement of mitochondrial function and oxidative stress production.