CompletedNot Applicable

High Altitude Muscle Recovery

United States8 participantsStarted 2023-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 trac…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Muscle Glycogen Concentrations

Timeframe: 6 hours

Phosphorylation status of rpS6

Timeframe: 6 hours

Trial details

NCT IDNCT06392373

SponsorUnited States Army Research Institute of Environmental Medicine

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-12-19

View on ClinicalTrials.gov More High Altitude trials