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

The Influence of Race and MitoQ Supplementation on Skin Perfusion 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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Natick, Massachusetts, United States, 01760
        • U.S. Army Research Institute of Environmental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo - Cold Water Hand Immersion
Four placebo (microcrystalline cellulose) capsules are taken ~1 hour before a 30-minute hand immersion in 54°F water.
Four placebo (microcrystalline cellulose) capsules are ingested orally.
Volunteers place one hand in cold (54°F) water for 30 minutes.
Placebo Comparator: Placebo - Cold Air Exposure
Four placebo (microcrystalline cellulose) capsules are taken ~1 hour before a 90-minute cold exposure in 41°F air.
Four placebo (microcrystalline cellulose) capsules are ingested orally.
Volunteers sit in cold (41°F) air for 90 minutes.
Experimental: MitoQ - Cold Water Hand Immersion
Four 20 mg MitoQ capsules (80 mg total) are taken ~1 hour before a 30-minute hand immersion in 54°F water.
Volunteers place one hand in cold (54°F) water for 30 minutes.
Four 20 mg MitoQ capsules (80 mg total) are ingested orally.
Experimental: MitoQ - Cold Air Exposure
Four 20 mg MitoQ capsules (80 mg total) are taken ~1 hour before a 90-minute cold exposure in 41°F air.
Volunteers sit in cold (41°F) air for 90 minutes.
Four 20 mg MitoQ capsules (80 mg total) are ingested orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
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.
Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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.
Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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.
Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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).
Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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).
Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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).
Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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.
Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
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.
Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
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.
Up to 2.5 hours after supplement dose on each cold air exposure study day
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.
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
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Actual)

October 28, 2025

Study Completion (Actual)

October 28, 2025

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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