The Influence of Race and MitoQ Supplementation on Skin Blood Flow in the Cold

NCT06784531 | Completed

• 2 other identifiers: 23-16HMO230093
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals who operate in cold weather are at risk of developing cold injuries, for example, frostbite. They also often experience a loss of hand function and joint mobility due to a decrease in skin temperature and blood flow. In addition, the risk of getting a cold injury is higher in the Black population compared to other racial and ethnic groups. Increases in oxidant compounds can cause the blood vessels in the skin to narrow and decrease skin temperature in the cold. However, it is unknown whether the higher risk of cold injury in Black individuals is because of a greater amount of oxidant compounds in the blood vessels. The purpose of this research is to see if an antioxidant supplement called MitoQ can help to improve skin temperature and blood flow in the cold and if the improvement is greater in Black individuals.

Conditions

Cold Exposure

Keywords

Skin blood flow; Skin temperature; Oxidative stress; Vasoconstriction; Cold stress; Racial disparities; Reactive oxygen species; Mitochondrial antioxidant; Mitoquinone; Mitoquinol; Manual dexterity; Peripheral cold injury

Outcome Measures

Primary Outcomes (2)

• Skin blood flow

  Skin blood flow is measured on the arm, hand, and finger using non-invasive laser probes. Output (red blood cell flux) will be divided by mean arterial blood pressure to give an index of cutaneous vascular conductance \[CVC, flux/mmHg\].

  Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day

• Body skin temperature

  Skin temperatures (°C) at 12 sites on the body will be measured using temperature sensors.

  Within 1 hour before and up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day

Secondary Outcomes (13)

• Manual dexterity

  Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day

• Finger strength

  Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day

• Hand strength

  Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day

• Body core temperature

  Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day

• Metabolic heat production

  Up to 2.5 hours after supplement dose on each cold air exposure study day

Study Arms (4)

Placebo - Cold Water Hand Immersion

PLACEBO COMPARATOR

Four placebo (microcrystalline cellulose) capsules are taken \~1 hour before a 30-minute hand immersion in 54°F water.

Dietary Supplement: Placebo; Other: Cold Water Hand Immersion

Placebo - Cold Air Exposure

PLACEBO COMPARATOR

Four placebo (microcrystalline cellulose) capsules are taken \~1 hour before a 90-minute cold exposure in 41°F air.

Dietary Supplement: Placebo; Other: Cold Air Exposure

MitoQ - Cold Water Hand Immersion

EXPERIMENTAL

Four 20 mg MitoQ capsules (80 mg total) are taken \~1 hour before a 30-minute hand immersion in 54°F water.

Dietary Supplement: Mitoquinone mesylate (MitoQ); Other: Cold Water Hand Immersion

MitoQ - Cold Air Exposure

EXPERIMENTAL

Four 20 mg MitoQ capsules (80 mg total) are taken \~1 hour before a 90-minute cold exposure in 41°F air.

Dietary Supplement: Mitoquinone mesylate (MitoQ); Other: Cold Air Exposure

Interventions

Mitoquinone mesylate (MitoQ) DIETARY_SUPPLEMENT

Four 20 mg MitoQ capsules (80 mg total) are ingested orally.

MitoQ - Cold Air Exposure; MitoQ - Cold Water Hand Immersion

Placebo DIETARY_SUPPLEMENT

Four placebo (microcrystalline cellulose) capsules are ingested orally.

Placebo - Cold Air Exposure; Placebo - Cold Water Hand Immersion

Cold Water Hand Immersion OTHER

Volunteers place one hand in cold (54°F) water for 30 minutes.

MitoQ - Cold Water Hand Immersion; Placebo - Cold Water Hand Immersion

Cold Air Exposure OTHER

Volunteers sit in cold (41°F) air for 90 minutes.

MitoQ - Cold Air Exposure; Placebo - Cold Air Exposure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, age 18-40
• In good health as determined by OMSO (Office of Medical Support and Oversight)
• Willing to refrain from exercise and caffeinated or alcoholic beverages for 12 hours before each testing session
• Willing to refrain from antioxidant-rich foods, such as blueberries, pecans, and dark chocolate, 48 h before each testing session
• Eumenorrheic females (menstrual cycle length between 24-35 days) or females taking oral contraceptives, or utilizing implantable contraception (e.g., intrauterine device)
• Have supervisor approval if active-duty military or a federal employee at NSSC

You may not qualify if:

• History of cold injuries of any severity (e.g., frostbite, trench foot, chilblains)
• Raynaud's syndrome
• Cold-induced asthma/bronchospasm
• Previous hand/finger injuries that impair dexterity and hand function
• Metal hardware (plates/screws) in the forearms and hands
• Smoke, vape, or use smokeless tobacco or other nicotine-containing products habitually (unless have quit \> 4 months prior)
• Current use of medications (except for birth control) or dietary supplements that could alter cardiovascular, thermoregulatory, or vascular control (e.g., anti-hypertensives, statins)
• History of disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery
• Have a history of renal disease including (but not limited to) chronic kidney disease, acute kidney injury, kidney stone disease, glomerular disease, or nephritis
• Known allergies to medical adhesives
• Known allergy to MitoQ
• Difficulty swallowing pills
• Heart, lung, kidney, muscle, or nerve disorder(s)
• A planned MRI during the study or within 3 days after completing a cold test
• Women who are pregnant, planning to become pregnant, or breastfeeding

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Interventions

mitoquinone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: September 16, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: April 30, 2026

Record last verified: 2025-12

Locations

US (1)