High Altitude Clinical Trial
— HAMROfficial title:
Skeletal Muscle Recovery From Aerobic Exercise During Acute High Altitude Exposure When Consuming Carbohydrate Compared to Carbohydrate Plus Protein
Verified date | April 2024 |
Source | United States Army Research Institute of Environmental Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To understand alterations in glycogen and molecular regulation of skeletal muscle glucose uptake, glycogen synthesis, and muscle protein recovery when consuming CHO (glucose) or CHO+PRO (glucose + whey) post-exercise during unacclimatized high altitude exposure, randomized crossover double blinded studies will be conducted in the hypobaric/hypoxic chamber at USARIEM Table 1. Briefly, the study consists of a 2 day baseline period at SL followed by two, 3 day trial periods (with the 3rd day being a testing day) at HA. The baseline is separated from trial 1 for a least a day, and trial 1 & 2 separated by at least 4 days. Volunteers will consume CHO (glucose) or CHO+PRO (glucose + whey) drinks post-exercise during unacclimatized high altitude exposure during the two trial periods. The order of the drinks will be randomized (using a random number generator such as randomizer.org) and kept by a study staff not directly involved in data collection to maintain blinding.
Status | Completed |
Enrollment | 8 |
Est. completion date | December 19, 2023 |
Est. primary completion date | December 19, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - Men and women aged 18 - 39 years - Physically active (exercise minimum 2-4 days per week) - Have supervisor approval (permanent party military and civilians at NSSC) - Willing to refrain from alcohol, nicotine products and dietary supplement use during the study - Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or using oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos) - Only consume caffeine products during the study if provided by study staff Exclusion Criteria: - Born at altitudes greater than 2,100 m (Subjects will inform the study team if they were born in Eagar AZ, Mammoth Lakes CA, CO, NM, UT, or WY). - Musculoskeletal injuries that compromise exercise capability - Metabolic or cardiovascular abnormalities, or gastrointestinal disorders (e.g. hypothyroidism, cardiovascular disease, Crohn's disease, etc.) - Taking medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise (e.g. thyroxine, beta blockers, insulin etc.) - Living in areas that are more than 1,200 m, or traveled to areas that are more than 1,200 m for five days or more within 2 months of data collection (e.g. Idaho Falls, ID; Denver, CO; etc.) - Prior diagnosis of high-altitude pulmonary edema or high-altitude cerebral edema - Presence of asthma or respiratory tract infections - Smoking or vaping (other forms of nicotine users, i.e., chewing tobacco will not be excluded; individuals who quit smoking or vaping for more than 90 days may be included) - Taking medications that interfere with oxygen delivery and transport (e.g. albuterol, EPO, etc.) - Hematocrit (HCT) <41% and Hemoglobin (HBG) <13.5 g/dL(Males), HCT <36% and HBG <12.0 g/dL (Females), and Sickle Cell Anemia/Trait - Whole blood donation within 8 weeks of the study - Unwilling or unable to only consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies - Unwilling or unable to adhere to study physical restrictions (abstain from exercise or recreational activities i.e., pick-up basketball during the study procedures) - Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test or self-report for breastfeeding will be obtained before body composition testing) |
Country | Name | City | State |
---|---|---|---|
United States | USARIEM | Natick | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
United States Army Research Institute of Environmental Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle Glycogen Concentrations | Determine the effects of of consuming a CHO (1.2 g CHO/kg/hr) compared to an isocaloric CHO+PRO (0.9 g CHO/kg/hr + 0.3 g PRO/kg/hr) supplement on post exercise muscle glycogen concentrations (umol/kg dry muscle weight) during the initial 6 hours of aerobic exercise recovery | 6 hours | |
Primary | Phosphorylation status of rpS6 | Determine the effects of of consuming a CHO (1.2 g CHO/kg/hr) compared to an isocaloric CHO+PRO (0.9 g CHO/kg/hr + 0.3 g PRO/kg/hr) supplement on post exercise muscle the fold change in the phosphorylation of rpS6 during the initial 6 hours of aerobic exercise recovery | 6 hours |
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