Clinical trial NCT01871142
Conditions: Hypoxia
Keywords: 5 Hydroxymethyl 2 Furfural AES103 Exercise
Sponsor: Colorado State University
Start date: 2013-03-01; Completion date: 2014-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Participants will receive, 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. Each intervention is separated by a 7 day washout period.
Interventions: intervention 1: Placebo intervention 2: Aes-103 intervention 3: Aes-103
Intervention descriptions: intervention 1: 100 mL intervention 2: Single dose of 1000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice intervention 3: Single dose of 3000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice

Protocol documents: