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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypoxia
 Dietary Supplement: Carbohydrate energy drink
Dietary Supplement: Aspartame
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: MEDEX Hidden Valley 2008

Resource links provided by NLM:

Drug Information available for: Aspartame
U.S. FDA Resources

Further study details as provided by Medical Expeditions Ltd:

Primary Outcome Measures:
  • Performance (time to complete a physical performance task) [ Time Frame: Mid study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Carbohydrate supplements (drinks and gels)
 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
Placebo Comparator: 2
Primarily Aspartame plus natural flavourings. Powder dissolved in water to provide non-distinguishable placebo drink.
 Dietary Supplement: Aspartame
Aspartame dissolved in water, ad libitum, 22 days.
Other Name: Science in Sport, Blackburn, UK

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Persons with Phenylketonuria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731510

Locations
United Kingdom
Medical Expeditions Ltd
Pinfold, Hyssington, Montgomery, Powys, United Kingdom, SY15 6AY
Sponsors and Collaborators
Medical Expeditions Ltd
Bangor University
Science in Sport
Plans Branch of Headquarters Army Recruiting and Training Division
Investigators
Principal Investigator: Jamie H Macdonald, PhD Bangor University
Principal Investigator: Samuel J Oliver, PhD Bangor University
  More Information

Additional Information:
MEDEX website expedition page  This link exits the ClinicalTrials.gov site

No publications provided by Medical Expeditions Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Simon Currin/Dr, Medical Expeditions Ltd
ClinicalTrials.gov Identifier: NCT00731510     History of Changes
Other Study ID Numbers: 08/WNo01/16
Study First Received: August 7, 2008
Last Updated: May 6, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Medical Expeditions Ltd:
Acute mountain sickness
Body composition,Hypoxia
Carbohydrate supplementation
Expedition,
 Hydration,
Hypoxia
Performance

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013