Clinical trial NCT06784531: The Influence of Race and MitoQ Supplementation on Skin Blood Flow in the Cold
Official title: The Influence of Race and MitoQ Supplementation on Skin Perfusion in the Cold
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
First posted: 2025-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Skin blood flow
timeFrame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
measure: Body skin temperature
timeFrame: 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:
measure: Manual dexterity
timeFrame: Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
measure: Finger strength
timeFrame: Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
measure: Hand strength
timeFrame: Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
measure: Body core temperature
timeFrame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
measure: Metabolic heat production
timeFrame: Up to 2.5 hours after supplement dose on each cold air exposure study day
measure: Blood pressure
timeFrame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
measure: Heart rate
timeFrame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
measure: Plasma MitoQ
timeFrame: 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
measure: Plasma malondialdehyde
timeFrame: 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
measure: Plasma total antioxidant status
timeFrame: 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
measure: Thermal comfort
timeFrame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
measure: Thermal sensation
timeFrame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
measure: Pain perception
timeFrame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
Other outcomes:
Locations:
city: Natick
country: United States
facility: U.S. Army Research Institute of Environmental Medicine
state: Massachusetts
Study officials:
References: