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

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Brief Title

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

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in Environmental Symptoms Questionnaire at High Altitude


Condition

Mountain Sickness

Intervention

Quercetin

Study Arms / Comparison Groups

 Quercetin
Description:  Quercetin: 500mg pill, twice daily for 5 days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

148

Start Date

August 2015

Completion Date

May 30, 2019

Primary Completion Date

September 2016

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
      

Gender

Male

Ages

18 Years - 30 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Robert Roach, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02463357

Organization ID

15-0254


Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver

Collaborators

 Alma College

Study Sponsor

Robert Roach, PhD, Principal Investigator, University of Colorado Anschutz Medical Campus, Altitude Research Center


Verification Date

March 2019