Health TrialsbyHealthPanel

Effects of an Antioxidant Supplement on Blood Vessel Health

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Georgia

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MitoQ, then PlaceboExperimental treatment 6 interventions
Group B: Placebo, then MitoQExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Cutaneous microvascular responses to local heating

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.

Time frame
1 hour post intervention
2

Flow-mediated dilation responses

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.

Time frame
1 hour post intervention
3

Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs)

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

Time frame
1 hour post intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Georgia

Lead sponsor

Source ClinicalTrials.gov
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