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| ID | Type | Description | Link |
|---|---|---|---|
| MO230093 | Other Grant/Funding Number | U.S. Army Medical Research and Development Command |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoquinone mesylate (MitoQ) | Dietary Supplement | Four 20 mg MitoQ capsules (80 mg total) are ingested orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S. Army Research Institute of Environmental Medicine | Natick | Massachusetts | 01760 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2025 | Dec 18, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| C429014 | mitoquinone |
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| Placebo | Dietary Supplement | Four placebo (microcrystalline cellulose) capsules are ingested orally. |
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| Cold Water Hand Immersion | Other | Volunteers place one hand in cold (54°F) water for 30 minutes. |
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| Cold Air Exposure | Other | Volunteers sit in cold (41°F) air for 90 minutes. |
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| Finger strength | 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 | 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 |
| Body core temperature | 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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day |