Effects of an antioxidant supplement on blood vessel health in healthy adults
Role of Mitochondria-derived Oxidative Stress on Microvascular Endothelial Function in Healthy Non-Hispanic Black and White Adults
This study is testing whether an antioxidant supplement can improve blood vessel health in healthy Black adults who may be at risk for heart problems.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Georgia Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Athens, Georgia) |
| Trial ID | NCT06424756 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of an antioxidant supplement on vascular function in healthy non-Hispanic Black adults, who are at higher risk for cardiovascular disease. It aims to determine if oxidative stress from mitochondria contributes to vascular dysfunction, potentially leading to hypertension and cardiovascular issues. Participants will receive either the antioxidant supplement MitoQ, MitoTempo, Tempol, or a placebo to assess changes in blood vessel health. The study focuses on understanding the role of oxidative stress in maintaining cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates are healthy non-Hispanic Black or non-Hispanic White adults aged 18-75 with normal blood pressure and cholesterol levels.
Not a fit: Patients with existing cardiovascular or metabolic diseases, skin disorders, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new preventative strategies for cardiovascular disease in at-risk populations.
How similar studies have performed: While there have been studies on antioxidants and vascular health, this specific focus on the non-Hispanic Black population and mitochondrial oxidative stress is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Athens, Georgia
- Ramsey Student Center, University of Georgia — Athens, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: S. Tony Wolf
- Email: stwolf@uga.edu
- Phone: 706-542-4378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.