- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06784531
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
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Natick, Massachusetts, United States, 01760
- U.S. Army Research Institute of Environmental Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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.
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Four placebo (microcrystalline cellulose) capsules are ingested orally.
Volunteers place one hand in cold (54°F) water for 30 minutes.
|
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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.
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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.
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Volunteers place one hand in cold (54°F) water for 30 minutes.
Four 20 mg MitoQ capsules (80 mg total) are ingested orally.
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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.
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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].
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Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
|
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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
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Skin temperatures (°C) at 12 sites on the body will be measured using temperature sensors.
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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.
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Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
|
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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
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Body core temperature (°C) is measured using a telemetry pill self-inserted as a suppository or ingested orally.
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Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
|
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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.
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Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
|
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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.
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Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
|
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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).
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Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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Thermal sensation
Time Frame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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Ratings of thermal sensation is assessed using a -50 to 50 scale (50 is extremely hot and -50 is extremely cold).
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Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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Pain perception
Time Frame: Up to 2.5 hours after supplement dose on each cold air exposure and cold water hand immersion study day
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Pain is assessed using a 0-10 scale (higher number is more pain).
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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
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Finger strength (kilograms) is measured using a pinch meter.
Participants will complete three pinch strength tests on each hand.
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Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
|
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Hand strength
Time Frame: Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
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Hand strength (kilograms) is measured on each hand using a grip strength meter.
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Within 1 hour before and approximately 2 hours after supplement dose on each cold air exposure study day
|
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Metabolic heat production
Time Frame: Up to 2.5 hours after supplement dose on each cold air exposure study day
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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.
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Up to 2.5 hours after supplement dose on each cold air exposure study day
|
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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
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Circulating concentrations of MitoQ (pmol/milliliter) is assessed in blood collected by venipuncture.
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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
|
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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
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Circulating concentrations of malondialdehyde (umol/liter) is assessed in blood collected by venipuncture.
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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
|
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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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-16H
- MO230093 (Other Grant/Funding Number: U.S. Army Medical Research and Development Command)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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