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Completed

NCT Number: NCT06784531

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

About this study

In a randomized, double-blinded, crossover design, healthy volunteers (18-40 yrs) will undergo a set of cold exposures following acute ingestion of a high-dose MitoQ supplement and placebo. The cold exposures will consist of a hand immersion in 54°F water and a 90-min exposure to 41°F air during which skin blood flow and temperatures will be measured. The hypothesis is that the declines in skin blood flow and temperature will be greater during cold exposure in Black individuals and that MitoQ supplementation will improve skin blood flow and temperature to a greater extent in Black individuals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Not willing to have small areas of skin on the body shaved (if deemed necessary for attachment of study instrumentation)
  • Have donated blood within 8 weeks of the study or plan to donate blood during the study
  • Lesions on a significant portion of the upper extremities due to skin pigmentation disorders (e.g., vitiligo, psoriasis)

Treatment and study plan

Mitoquinone mesylate (MitoQ)

Dietary Supplement

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

Placebo

Dietary Supplement

Four placebo (microcrystalline cellulose) capsules are ingested orally.

Cold Water Hand Immersion

Other

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

Cold Air Exposure

Other

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

Primary outcomes

  1. Skin blood flow

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

    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].

  2. Body skin temperature

    Time frame: 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

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

Secondary outcomes

  1. Manual dexterity

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

    Manual dexterity is assessed by placing pegs into a pegboard, moving small blocks on a table, and placing bullets into magazines. Scores are the number of pegs placed into the board in 1 minute, the time (seconds) required to move small blocks various distances on the table, and the number of bullets placed into magazines in 2 minutes.

  2. Finger strength

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

    Finger strength (kilograms) is measured using a pinch meter. Participants will complete three pinch strength tests on each hand.

  3. Hand strength

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

    Hand strength (kilograms) is measured on each hand using a grip strength meter.

  4. Body core temperature

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

    Body core temperature (°C) is measured using a telemetry pill self-inserted as a suppository or ingested orally.

  5. Metabolic heat production

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

    Oxygen consumption (liters/minute) and carbon dioxide production (liters/minute) are measured by breathing into a mouthpiece connected to a metabolic cart for ~5 minutes. Oxygen consumption and carbon dioxide production will be combined to report metabolic heat production in Watts per meter squared.

  6. Blood pressure

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

    Brachial artery blood pressure (mmHg) is measured using an automated cuff.

  7. Heart rate

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

    Heart rate (beats per minute) is measured using an automated cuff.

  8. Plasma MitoQ

    Time frame: Within 30 minutes before, 1 hour after, and 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day

    Circulating concentrations of MitoQ (pmol/milliliter) is assessed in blood collected by venipuncture.

  9. Plasma malondialdehyde

    Time frame: Within 30 minutes before, 1 hour after, and 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day

    Circulating concentrations of malondialdehyde (umol/liter) is assessed in blood collected by venipuncture.

  10. Plasma total antioxidant status

    Time frame: Within 30 minutes before, 1 hour after, and 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day

    Total antioxidant status (mmol/liter) is assessed in blood collected by venipuncture.

  11. Thermal comfort

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

    Thermal comfort is assessed using a 1-7 scale (higher number is more discomfort).

  12. Thermal sensation

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

    Ratings of thermal sensation is assessed using a -50 to 50 scale (50 is extremely hot and -50 is extremely cold).

  13. Pain perception

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

    Pain is assessed using a 0-10 scale (higher number is more pain).

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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