Hypoxia Clinical Trial
Official title:
Double-Blind, Placebo Controlled Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance in Healthy Adult Humans
In low oxygen environments, such as high-altitude, some adults may become ill and suffer
from acute mountain sickness. Further, all adults will find that exercising becomes much
more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose
of this investigation is to study the effects of a new medicine called Aes-103. A company
called AesRx, LLC makes this medicine. The active ingredient in the medicine is
5-Hydroxymethyl-2-Furfural (5HMF), a naturally occurring substance that can be found in
coffee, honey, dried fruits, fruit juices, malt, barley, Balsamic vinegar and caramel.The
investigators believe that Aes-103 may help people adjust to high-altitude quickly and
prevent them from becoming ill. The purpose of the study is to determine if Aes-103 will
promote endurance performance in low oxygen environments in healthy adult humans.
Aes-103 is currently being investigated by AesRx, LLC (Newton, MA) in collaboration with the
National Heart, Lung and Blood Institute of the NIH (Bethesda, MD) as a potential
anti-sickling agent in sickle cell disease. Sickle-cell disease is characterized by problems
in blood that prevent blood cells from carrying oxygen. Aes-103 might be able to help blood
cells carry more oxygen. It is for this reason that the investigators in this study believe
Aes-103 might help people adjust to high-altitude quickly.
There are no known special safety considerations with the active ingredient in Aes-103
(5-HMF). In recent, placebo controlled, clinical safety tests, Aes-103 was given in single
doses of 300 mg, 1000 mg,2000 mg and 4000 mg to healthy normal volunteers. Additionally, the
toxicological effects of Aes-103 have been studied when given acutely, sub-acutely, and
chronically in rodents, and for up to 28 days in dogs. Based on these safety studies, single
doses of Aes-103 are expected to have no significant negative/toxicological effect at the
doses being evaluated in this study.
This is a randomized, placebo-controlled, double-blind blind, repeated measures (cross-over)
study. Approximately 12 healthy adult men will consume, in a random order, a placebo prior
to exercise in normoxia, a placebo prior to exercise in hypoxia, 1000 mg of Aes-103 prior to
exercise in hypoxia, and 3000 mg of Aes-103 prior to exercise in hypoxia.
Study participants will report to the Human Performance/Clinical Research Laboratory (HPCRL)
on 6 separate occasions. On visit 1 study participants will undergo screening (e.g. medical
history and 12-lead electrocardiogram and blood pressure at rest and during incremental
exercise to volitional exhaustion), and will be instructed to avoid foods and drinks high in
5-HMF (e.g., coffee, malt, barley, dried fruits, and caramel) for at least 3 days before
each subsequent visit. Visit 2 will comprise of a habituation visit during which subjects
will be given the opportunity to rehearse the exercise test. Visits 3, 4, 5 and 6, will
occur in a random order and be almost identical in nature. Study participants will abstain
from vigorous physical exercise and alcohol consumption during the 24-hours prior to each
visit. In addition, study participants will abstain from all food and beverages, except
water, during the 4-hours prior to visits 3, 4, 5 and 6. On arrival subjects will be
instrumented for measurement of heart rate, blood pressure and blood oxygen saturation.
Following baseline determination subjects will consume either: a placebo, 1000 mg of Aes-103
or 3000 mg of Aes-103. 45 minutes after consumption, participants will enter our
environmental chamber, adjusted randomly to either normoxia (21% oxygen) or hypoxia (15%
oxygen). The pairing of normoxia/hypoxia and supplement will be as follows: placebo +
normoxia, placebo + hypoxia, 1000 mg + hypoxia, and 3000 mg + hypoxia. Participants will
remain seated in the environmental chamber for 15 minutes, after which they will complete a
standardized warm-up bout of exercise (100 W for 30 minutes) followed by a brief time trial
(time taken to cycle 12.5 km (~7.75 miles)). Heart rate, blood pressure and blood oxygen
saturation will be recorded every 5 minutes. During exercise, subjective ratings of
perceived exertion (Borg Scale) will be recorded every 10 minutes, and at end-exercise.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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