Three New Ideas to Protect Special Forces From the Stress of High Altitude



Status:Active, not recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 30
Updated:3/10/2019
Start Date:August 2015
End Date:May 30, 2019

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Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of
non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric
pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS.
Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and
difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance
and endurance exercise capacity are impaired. Therefore, the goal of this research is to
identify effective pharmacological agents that will help reduce the symptoms of AMS and
improve physical and cognitive performance at high altitude.

The investigators will study the efficacy of the dietary supplement, quercetin, the drugs
nifedipine (extended release) and methazolamide taken together, the drug metformin, and the
drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at
high altitudes.


Inclusion Criteria:

- healthy,

- young (18-30 years old) men who can meet APFT requirements for special operation
forces (SOF) training as outlined by the US Army (42 push ups, 53 sit-ups, 6 pull-ups,
2 mile run in < 15 min 54 s)

Exclusion Criteria:

- women;

- smokers;

- participants with diseases or disorders known to be affected by hypoxia or the drugs
used in this study, such as hypotension, anemia, sickle cell trait or disease, and
diabetes;

- participants with a history of significant head injury, migraines or seizures;

- participants taking any medication (over-the-counter or prescription) or herbal
supplements;

- participants with known flavonoid allergies;

- participants with known allergies to metformin;

- participants with known hypersensitivity reaction to nifedipine;

- participants with known allergies to sulfonamide-based drugs;

- participants with inability to be headache-free when consuming the amount of caffeine
in two six ounce cups of coffee or less per day;

- exposure to high altitude above 1000m in the previous three months; or

- participants who have been on an airline flight over six hours (the lowered cabin
pressure for an extended period of time approximates exposure to high altitude);

- participants who are unable to achieve the minimum physical criteria required for SOF
training
We found this trial at
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Alma, Michigan 48801
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Alma, MI
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