Effects of an Antioxidant Supplement on Blood Vessel Health

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424756
• Other study ID #: PROJECT00009286
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: March 31, 2030

Study information

• Verified date: June 2024
• Source: University of Georgia
• Contact: S. Tony Wolf
• Phone: 706-542-4378
• Email: stwolf[@]uga.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 31, 2030
• Est. primary completion date: March 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Self-identify as either non-Hispanic Black or non-Hispanic White.

• Men and women 18-30 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• MitoQ
MitoQ supplement is composed of mitoquinol mesylate, which is a synthetic analog of coenzyme Q10
• Placebo
MitoQ matched Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
S. Tony Wolf

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour post intervention
Primary	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.	1 hour post intervention
Primary	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.	1 hour post intervention