Cold ExposureNCT06784531
The Influence of Race and MitoQ Supplementation on Skin Blood Flow in the Cold
A study testing Mitoquinone mesylate (MitoQ), Cold Water Hand Immersion and Cold Air Exposure in people with Cold Exposure, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Exposure
- What is being tested?
- Mitoquinone mesylate (MitoQ), Cold Water Hand Immersion and Cold Air Exposure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
Official title: 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.
Read the 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.
- Conditions
- Cold Exposure
- Being tested
- Mitoquinone mesylate (MitoQ), Placebo, Cold Water Hand Immersion, Cold Air 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoquinone mesylate (MitoQ)Dietary supplement
Four 20 mg MitoQ capsules (80 mg total) are ingested orally.
PlaceboDietary supplement
Four placebo (microcrystalline cellulose) capsules are ingested orally.
Cold Water Hand ImmersionOther
Volunteers place one hand in cold (54°F) water for 30 minutes.
Cold Air ExposureOther
Volunteers sit in cold (41°F) air for 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Mitoquinone mesylate (MitoQ); Other: Cold Air Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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.
Measured: 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
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.
Measured: Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
Finger strength
Finger strength (kilograms) is measured using a pinch meter. Participants will complete three pinch strength tests on each hand.
Measured: Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
Hand strength
Hand strength (kilograms) is measured on each hand using a grip strength meter.
Measured: Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
Body core temperature
Body core temperature (°C) is measured using a telemetry pill self-inserted as a suppository or ingested orally.
Measured: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
Metabolic heat production
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.
Measured: Up to 2.5 hours after supplement dose on each cold air exposure study day
Blood pressure
Brachial artery blood pressure (mmHg) is measured using an automated cuff.
Measured: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
Heart rate
Heart rate (beats per minute) is measured using an automated cuff.
Measured: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
Plasma MitoQ
Circulating concentrations of MitoQ (pmol/milliliter) is assessed in blood collected by venipuncture.
Measured: 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
Circulating concentrations of malondialdehyde (umol/liter) is assessed in blood collected by venipuncture.
Measured: 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
Total antioxidant status (mmol/liter) is assessed in blood collected by venipuncture.
Measured: 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
Thermal comfort
Thermal comfort is assessed using a 1-7 scale (higher number is more discomfort).
Measured: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
Thermal sensation
Ratings of thermal sensation is assessed using a -50 to 50 scale (50 is extremely hot and -50 is extremely cold).
Measured: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
Pain perception
Pain is assessed using a 0-10 scale (higher number is more pain).
Measured: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start16 Sep 2024
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784531
- Sponsor's protocol ID
- 23-16H
- Other IDs
- MO230093
- Status last verified
- Dec 2025
- First submitted
- 14 Jan 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Race and MitoQ Supplementation on Skin Perfusion in the Cold
- ClinicalTrials.gov ID
- NCT06784531
- Acronym / sponsor ID
- 23-16H
- Conditions
- Cold Exposure
- Keywords
- Skin blood flow, Skin temperature, Oxidative stress, Vasoconstriction, Cold stress, Racial disparities, Reactive oxygen species, Mitochondrial antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo - Cold Water Hand Immersion | Placebo comparator | Dietary Supplement: Placebo, Other: Cold Water Hand ImmersionFour placebo (microcrystalline cellulose) capsules are taken ~1 hour before a 30-minute hand immersion in 54°F water. |
| Placebo - Cold Air Exposure | Placebo comparator | Dietary Supplement: Placebo, Other: Cold Air ExposureFour placebo (microcrystalline cellulose) capsules are taken ~1 hour before a 90-minute cold exposure in 41°F air. |
| MitoQ - Cold Water Hand Immersion | Experimental | Dietary Supplement: Mitoquinone mesylate (MitoQ), Other: Cold Water Hand ImmersionFour 20 mg MitoQ capsules (80 mg total) are taken ~1 hour before a 30-minute hand immersion in 54°F water. |
| MitoQ - Cold Air Exposure | Experimental | Dietary Supplement: Mitoquinone mesylate (MitoQ), Other: Cold Air ExposureFour 20 mg MitoQ capsules (80 mg total) are taken ~1 hour before a 90-minute cold exposure in 41°F air. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoquinone mesylate (MitoQ)Four 20 mg MitoQ capsules (80 mg total) are ingested orally. | Dietary supplement | MitoQ - Cold Air Exposure, MitoQ - Cold Water Hand Immersion |
| PlaceboFour placebo (microcrystalline cellulose) capsules are ingested orally. | Dietary supplement | Placebo - Cold Air Exposure, Placebo - Cold Water Hand Immersion |
| Cold Water Hand ImmersionVolunteers place one hand in cold (54°F) water for 30 minutes. | Other | MitoQ - Cold Water Hand Immersion, Placebo - Cold Water Hand Immersion |
| Cold Air ExposureVolunteers sit in cold (41°F) air for 90 minutes. | Other | MitoQ - Cold Air Exposure, Placebo - Cold Air Exposure |
Primary outcome
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].
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.
13 secondary outcomes
Manual dexterity
Time frame: Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
Finger strength
Time frame: 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
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
Metabolic heat production
Time frame: Up to 2.5 hours after supplement dose on each cold air exposure 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
Heart rate
Time frame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion 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
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
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
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 sensation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitoquinone mesylate (MitoQ), Cold Water Hand Immersion and Cold Air Exposure in people with Cold Exposure, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.