Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2018-11-28
2020-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Sea Level
Carbohydrate metabolism measured at SL
Sea Level
Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
High Altitude
Carbohydrate metabolism measured at HA
High Altitude
Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
Interventions
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Sea Level
Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
High Altitude
Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
Eligibility Criteria
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Inclusion Criteria
* Born at altitudes less than 2,100 m (\~7,000 feet; Examples include Santa Fe, New Mexico; Laramie, Wyoming; Etc.)
* Physically active based on assessment of physical activity history (2-4 days per week aerobic and/or resistance exercise)
* Have supervisor approval (permanent party military and civilians)
* Willing to refrain from alcohol, smokeless nicotine products and dietary supplement use during study periods
* Refrain from taking any nonsteroidal anti-inflammatory drugs (NSAIDs; e.g. aspirin, Advil®, Aleve®, Naprosyn®, or any aspirin-containing product) for 10 days before and at least 5 days AFTER each muscle biopsy. (\*Tylenol® or acetaminophen is ok to use if needed for discomfort)
Exclusion Criteria
* Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months (Examples include Ft. Huachuca, Arizona; Lima, Peru; Feldberg, Germany, Etc.)
* Musculoskeletal injuries that compromise exercise capability
* Metabolic or cardiovascular abnormalities (determined by resting ECG), gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
* Medication that affects macronutrient metabolism (i.e., diabetes medications, statins, corticosteroids, etc) and/or the ability to participate in strenuous exercise
* Evidence of apnea or other sleeping disorders
* Prior diagnosis of high altitude pulmonary edema (HAPE) or high altitude cerebral edema (HACE)
* Presence of asthma or respiratory tract infections (\< 1 month prior)
* Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine ) to be utilized in the study
* Smoking or vaping
* History of complications with lidocaine
* Taking medications that interfere with oxygen delivery and transport (Includes sedatives, sleeping aids, tranquilizers and/or any medication that depresses ventilation, diuretics, alpha and beta blockers)
* Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous as determined by the Office of Medical Support and Oversight
* Present condition of alcoholism, anabolic steroids, or other substance abuse issues
* Anemia (hematocrit \<38% and hemoglobin \<12.5 g/dL) and Sickle Cell Anemia/Trait
* Abnormal prothrombin time (PT)/ partial thromboplastin time (PTT) test or problems with blood clotting
* Blood donation within 8 weeks of beginning the study
18 Years
39 Years
MALE
Yes
Sponsors
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University of Arkansas
OTHER
United States Army Research Institute of Environmental Medicine
FED
Responsible Party
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Principal Investigators
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Lee M Margolis, PhD
Role: PRINCIPAL_INVESTIGATOR
Military Nutrition Division, USARIEM
Locations
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USARIEM
Natick, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18-09HC
Identifier Type: -
Identifier Source: org_study_id
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