Design and conduct of 'Xtreme Alps': a double-blind, randomised controlled study of the effects of dietary nitrate supplementation on acclimatisation to high altitude
Martin DS, Gilbert-Kawai ET, Meale PM, Fernandez BO, Cobb A, Khosravi M, Mitchell K, Grocott MP, Levett DZ, Mythen MG, Feelisch M, Xtreme Alps Research Group
Contemporary clinical trials · 13 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute for Health and Care Research
- Organización sin fines de lucro
- Academy of Medical Sciences
- Gobierno
- National Institute for Health Research (NIHR)
- Subvenciones
- National Institute for Health and Care Research (ACF-2012-18-015); Academy of Medical Sciences (AMS-CSF3-Mole); National Institute for Health and Care Research (ACF-2009-13-013)
Según 3 financiadores declarados.
Publicación
- Publicado
- 2013-09-10 · Contemp Clin Trials · vol. 36 · número 2 · págs. 450–459
- Editorial
- Elsevier BV
- Citado
- 13 citas · más que el 80% de estudios similares · 1.2× el promedio de su campo
- Referencias
- 31 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- High Altitude and Hypoxia · Nitric Oxide and Endothelin Effects · Thermoregulation and physiological responses
- Palabras clave
- nitrate supplementation, beetroot juice, hypobaric hypoxia, nitric oxide, exercise capacity, microvascular blood flow, tissue oxygenation
- MeSH
- forearm, muscle, skeletal, saliva, humans, altitude sickness, nitrates, oxygen, echocardiography, cardiac output, spirometry, clinical protocols, exercise, double-blind method, acclimatization, dietary supplements, adult, italy, female, male, young adult, hypoxia
11 autores
- Daniel Martín🇬🇧 · autor de correspondenciaThe Royal Free Hospital; University College London
- Edward T. Gilbert-Kawai🇬🇧University College London
- Paula Meale🇬🇧The Royal Free Hospital; University College London
- Bernadette O. Fernandez🇬🇧Southampton General Hospital; University of Warwick; University of Southampton
- Alexandra Cobb🇬🇧University College London
- Maryam Khosravi🇬🇧University College London
- Kay Mitchell🇬🇧University College London
- Michael P. W. Grocott🇬🇧Southampton General Hospital; University Hospital Southampton NHS Foundation Trust; University of Southampton; University College London
- Denny Z H Levett🇬🇧University College London
- Michael G. Mythen🇬🇧University College London
- Martin Feelisch🇬🇧Southampton General Hospital; University of Warwick; University of Southampton
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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