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MEDEX Hidden Valley 2008

This study has been completed.
Sponsor:
Collaborators:
Bangor University
Science in Sport
Plans Branch of Headquarters Army Recruiting and Training Division
Information provided by (Responsible Party):
Medical Expeditions Ltd
ClinicalTrials.gov Identifier:
NCT00731510
First received: August 7, 2008
Last updated: March 30, 2017
Last verified: March 2017
August 7, 2008
March 30, 2017
June 2008
October 2008   (Final data collection date for primary outcome measure)
Performance (time to complete a physical performance task) [ Time Frame: Mid study ]
Same as current
Complete list of historical versions of study NCT00731510 on ClinicalTrials.gov Archive Site
  • Body composition [ Time Frame: Pre, mid and post study ]
  • Hydration status [ Time Frame: Pre, mid and post study ]
  • Body glucose stores [ Time Frame: Pre, mid and post study ]
  • Oxygen delivery [ Time Frame: Pre, mid and post study ]
  • Acute mountain sickness [ Time Frame: Every day ]
  • Spontaneous physical activity level [ Time Frame: Pre, mid and post study ]
  • Rating of perceived exertion during a stepping task [ Time Frame: Pre, mid and post study ]
Same as current
Not Provided
Not Provided
 
MEDEX Hidden Valley 2008
MEDEX Hidden Valley 2008

During a multi−week expedition to the Himalaya, we aim to investigate i) whether dietary supplementation with carbohydrate drinks and gels can improve physical performance; and ii) the underlying mechanisms for any observed changes in performance.

We hypothesise that i) carbohydrate supplementation will improve physical performance; and ii) the underlying mechanism of this improvement in performance will include maintenance of body glycogen (sugar) stores, prevention of dehydration and decrease in the incidence of acute mountain sickness.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Hypoxia
  • Dietary Supplement: Carbohydrate energy drink
    Complex carbohydrates including maltodextrin (97%) dissolved in water to make a a 10% solution, or dissolved in 25mL gels. Ad libitum. Twenty two days.
    Other Name: PSP22 Energy, Science in Sport, Blackburn, UK
  • Dietary Supplement: Aspartame
    Aspartame dissolved in water, ad libitum, 22 days.
    Other Name: Science in Sport, Blackburn, UK
  • Experimental: 1
    Carbohydrate supplements (drinks and gels)
    Intervention: Dietary Supplement: Carbohydrate energy drink
  • Placebo Comparator: 2
    Primarily Aspartame plus natural flavourings. Powder dissolved in water to provide non-distinguishable placebo drink.
    Intervention: Dietary Supplement: Aspartame
Macdonald JH, Oliver SJ, Hillyer K, Sanders S, Smith Z, Williams C, Yates D, Ginnever H, Scanlon E, Roberts E, Murphy D, Lawley J, Chichester E. Body composition at high altitude: a randomized placebo-controlled trial of dietary carbohydrate supplementation. Am J Clin Nutr. 2009 Nov;90(5):1193-202. doi: 10.3945/ajcn.2009.28075. Epub 2009 Sep 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • a healthy enthusiasm for the outdoors and/or a passion for research in remote and difficult circumstances

Exclusion Criteria:

  • Persons with Phenylketonuria
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00731510
08/WNo01/16
No
Not Provided
Not Provided
Medical Expeditions Ltd
Medical Expeditions Ltd
  • Bangor University
  • Science in Sport
  • Plans Branch of Headquarters Army Recruiting and Training Division
Principal Investigator: Jamie H Macdonald, PhD Bangor University
Principal Investigator: Samuel J Oliver, PhD Bangor University
Medical Expeditions Ltd
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP