MEDEX Hidden Valley 2008

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Medical Expeditions Ltd.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Bangor University
Science in Sport
Plans Branch of Headquarters Army Recruiting and Training Division
Information provided by:
Medical Expeditions Ltd
ClinicalTrials.gov Identifier:
NCT00731510
First received: August 7, 2008
Last updated: May 6, 2009
Last verified: September 2008

August 7, 2008
May 6, 2009
June 2008
October 2008   (final data collection date for primary outcome measure)
Performance (time to complete a physical performance task) [ Time Frame: Mid study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Hydration status [ Time Frame: Pre, mid and post study ] [ Designated as safety issue: No ]
  • Body glucose stores [ Time Frame: Pre, mid and post study ] [ Designated as safety issue: No ]
  • Oxygen delivery [ Time Frame: Pre, mid and post study ] [ Designated as safety issue: No ]
  • Acute mountain sickness [ Time Frame: Every day ] [ Designated as safety issue: Yes ]
  • Spontaneous physical activity level [ Time Frame: Pre, mid and post study ] [ Designated as safety issue: No ]
  • Rating of perceived exertion during a stepping task [ Time Frame: Pre, mid and post study ] [ Designated as safety issue: No ]
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
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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. Epub 2009 Sep 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00731510
08/WNo01/16
No
Simon Currin/Dr, 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
September 2008

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