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MEDEX Hidden Valley 2008

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ClinicalTrials.gov Identifier: NCT00731510
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : March 31, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Hypoxia Dietary Supplement: Carbohydrate energy drink Dietary Supplement: Aspartame

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: MEDEX Hidden Valley 2008
Study Start Date : June 2008
Primary Completion Date : October 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Performance (time to complete a physical performance task) [ Time Frame: Mid study ]

Secondary Outcome Measures :
  1. Body composition [ Time Frame: Pre, mid and post study ]
  2. Hydration status [ Time Frame: Pre, mid and post study ]
  3. Body glucose stores [ Time Frame: Pre, mid and post study ]
  4. Oxygen delivery [ Time Frame: Pre, mid and post study ]
  5. Acute mountain sickness [ Time Frame: Every day ]
  6. Spontaneous physical activity level [ Time Frame: Pre, mid and post study ]
  7. Rating of perceived exertion during a stepping task [ Time Frame: Pre, mid and post study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731510

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
Principal Investigator: Jamie H Macdonald, PhD Bangor University
Principal Investigator: Samuel J Oliver, PhD Bangor University
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Expeditions Ltd
ClinicalTrials.gov Identifier: NCT00731510     History of Changes
Other Study ID Numbers: 08/WNo01/16
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

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

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