Status:
COMPLETED
High Altitude and Exogenous Carbohydrate Oxidation
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Collaborating Sponsors:
University of Arkansas
Conditions:
Glucose Metabolism
High Altitude
Eligibility:
MALE
18-39 years
Phase:
NA
Brief Summary
Recent studies have reported that oxidation of exogenous carbohydrate is reduced under acute hypobaric hypoxic (high altitude; HA) conditions compared to normoxia (sea level; SL) in native lowlanders....
Detailed Description
This randomized crossover study will examine substrate metabolic responses to ingesting supplemental carbohydrate during steady-state aerobic-type exercise at sea level (SL) and following acute (\~5 h...
Eligibility Criteria
Inclusion
- Men aged 18 - 39 years
- 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
- Born at altitudes greater than 2,100 m (\~7,000 feet; Examples include Santa Fe, New Mexico; Laramie, Wyoming; Etc.)
- 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
Key Trial Info
Start Date :
November 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03851744
Start Date
November 28 2018
End Date
September 1 2020
Last Update
September 2 2021
Active Locations (1)
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1
USARIEM
Natick, Massachusetts, United States, 01760