Clinical trial NCT02463357: Three New Ideas to Protect Special Forces From the Stress of High Altitude
Official title: Three New Ideas to Protect Special Forces From the Stress of High Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mountain Sickness
Keywords: Exercise, Aerobic
Cognitive Function
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Alma College
First posted: 2015-06-04
Enrollment: 148
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Environmental Symptoms Questionnaire at High Altitude
timeFrame: Baseline and during high altitude exposure (3 days, AM/PM)
measure: Change in Lake Louise AMS Scoring System at High Altitude
timeFrame: Baseline and during high altitude exposure (3 days, AM/PM)
measure: Change in Army Physical Fitness Test (APFT) at High Altitude
timeFrame: Baseline, 1st day at high altitude
measure: Change in Uphill Hike at High Altitude
timeFrame: 2nd day at altitude
measure: Change in Defense Automated Neurobehavioral Assessment (DANA) Reaction Time at High Altitude
timeFrame: Baseline and and 1st day at high altitude
Secondary outcomes:
Other outcomes:
Locations:
city: Alma
country: United States
facility: Alma College
state: Michigan
Study officials:
affiliation: University of Colorado Anschutz Medical Campus, Altitude Research Center
name: Robert Roach, PhD
role: PRINCIPAL_INVESTIGATOR
References: