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Design and conduct of 'Xtreme Alps' : a double-blind, randomised controlled study of the effects of dietary nitrate supplementation on acclimatisation to high altitude
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Martin, Daniel S., Gilbert-Kawai, Edward T., Meale, Paula M., Fernandez, Bernadette O., Cobb, Alexandra, Khosravi, Maryam, Mitchell, Kay, Grocott, Michael P.W., Levett, Denny Z.H., Mythen, Monty and Feelisch, Martin (2013) Design and conduct of 'Xtreme Alps' : a double-blind, randomised controlled study of the effects of dietary nitrate supplementation on acclimatisation to high altitude. Contemporary Clinical Trials, Volume 36 (Number 2). pp. 450-459. doi:10.1016/j.cct.2013.09.002 ISSN 1551-7144.
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Official URL: http://dx.doi.org/10.1016/j.cct.2013.09.002
Abstract
The study of healthy human volunteers ascending to high altitude provides a robust model of the complex physiological interplay that emulates human adaptation to hypoxaemia in clinical conditions. Nitric oxide (NO) metabolism may play an important role in both adaptation to high altitude and response to hypoxaemia during critical illness at sea level. Circulating nitrate and nitrite concentrations can be augmented by dietary supplementation and this is associated with improved exercise performance and mitochondrial efficiency. We hypothesised that the administration of a dietary substance (beetroot juice) rich in nitrate would improve oxygen efficiency during exercise at high altitude by enhancing tissue microcirculatory blood flow and oxygenation. Furthermore, nitrate supplementation would lead to measurable increases in NO bioactivity throughout the body.
This methodological manuscript describes the design and conduct of the ‘Xtreme Alps’ expedition, a double-blind randomised controlled trial investigating the effects of dietary nitrate supplementation on acclimatisation to hypobaric hypoxia at high altitude in healthy human volunteers. The primary outcome measure was the change in oxygen efficiency during exercise at high altitude between participants allocated to receive nitrate supplementation and those receiving a placebo. A number of secondary measures were recorded, including exercise capacity, peripheral and microcirculatory blood flow and tissue oxygenation.
Results from this study will further elucidate the role of NO in adaption to hypoxaemia and guide clinical trials in critically ill patients. Improved understanding of hypoxaemia in critical illness may provide new therapeutic avenues for interventions that will improve survival in critically ill patients.
| Item Type: | Journal Article | ||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||
| Library of Congress Subject Headings (LCSH): | Clinical trials, Evidence-based medicine, Anoxemia, Nitric oxide, Critical care medicine, Microcirculation | ||||
| Journal or Publication Title: | Contemporary Clinical Trials | ||||
| Publisher: | Elsevier Science Inc. | ||||
| ISSN: | 1551-7144 | ||||
| Official Date: | November 2013 | ||||
| Dates: |
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| Volume: | Volume 36 | ||||
| Number: | Number 2 | ||||
| Page Range: | pp. 450-459 | ||||
| DOI: | 10.1016/j.cct.2013.09.002 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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