## Protocol Section
### Identification Module
**NCT ID:** NCT06424756

**Brief Title:** Effects of an Antioxidant Supplement on Blood Vessel Health

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

#### Organization Study ID Info
**ID:** PROJECT00009286
#### Organization
**Class:** OTHER
**Full Name:** University of Georgia
### Status Module
#### Completion Date
**Date:** 2030-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2030-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** S. Tony Wolf

#### Responsible Party

**Investigator Affiliation:** University of Georgia

**Investigator Full Name:** S. Tony Wolf

**Investigator Title:** Assistant Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Vascular dysfunction

- Cardiovascular disease

- Hypertension

- Nitric oxide

- Endothelial function

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** For the experimental visits, participants will receive an antioxidant supplement in capsule form or a matching placebo pill in a randomized, double-blinded, crossover fashion. During each visit, participants will be given a single dose of the treatment to which they are randomized upon arrival at the laboratory (i.e., either 80 mg MitoQ or placebo will be administered on Visit 3, and the other treatment will be given on Visit 4). Peak concentrations of the antioxidant (MitoQ) occur after approximately 1 hour, allowing for appropriate time to prepare the participant for the experimental procedures.

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days

**Intervention Names:**

- Dietary Supplement: MitoQ

- Dietary Supplement: Placebo

**Label:** MitoQ, then Placebo

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days

**Intervention Names:**

- Dietary Supplement: MitoQ

- Dietary Supplement: Placebo

**Label:** Placebo, then MitoQ

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MitoQ, then Placebo

- Placebo, then MitoQ

**Description:** MitoQ supplement is composed of mitoquinol mesylate, which is a synthetic analog of coenzyme Q10

**Name:** MitoQ

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- MitoQ, then Placebo

- Placebo, then MitoQ

**Description:** MitoQ matched Placebo

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Cutaneous microvascular responses to local heating

**Time Frame:** 1 hour post intervention

**Description:** 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.

**Measure:** Flow-mediated dilation responses

**Time Frame:** 1 hour post intervention

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

**Measure:** Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs)

**Time Frame:** 1 hour post intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Self-identify as either non-Hispanic Black or non-Hispanic White.
* Men and women 18-60 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.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** stwolf@uga.edu

**Name:** S. Tony Wolf

**Phone:** 706-542-4378

**Role:** CONTACT

**Contact 2:**

**Email:** mgorejena@uga.edu

**Name:** Melissa Gorejena

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M17201

- Name: Ubiquinone

- Relevance: LOW

- As Found: Unknown

- ID: M271049

- Name: Coenzyme Q10

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M12507

- Name: Nitric Oxide

- Relevance: LOW

- As Found: Unknown

- ID: T383

- Name: Coenzyme Q10

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
