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NCT00731510 Clinical Trial

MEDEX Hidden Valley 2008

Hypoxia Clinical Trial

Official title:
MEDEX Hidden Valley 2008

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00731510
Other study ID # 08/WNo01/16
Secondary ID
Status Completed
Phase N/A
First received August 7, 2008
Last updated March 30, 2017
Start date June 2008
Est. completion date December 2008

Study information
Verified date March 2017
Source Medical Expeditions Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date December 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Persons with Phenylketonuria

Study Design

Related Conditions & MeSH terms

Intervention

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.
• Aspartame
Aspartame dissolved in water, ad libitum, 22 days.

Locations
Country Name City State
United Kingdom Medical Expeditions Ltd Pinfold, Hyssington, Montgomery Powys

Sponsors (4)
Lead Sponsor Collaborator
Medical Expeditions Ltd Bangor University, Plans Branch of Headquarters Army Recruiting and Training Division, Science in Sport

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Performance (time to complete a physical performance task) Mid study
Secondary Body composition Pre, mid and post study
Secondary Hydration status Pre, mid and post study
Secondary Body glucose stores Pre, mid and post study
Secondary Oxygen delivery Pre, mid and post study
Secondary Acute mountain sickness Every day
Secondary Spontaneous physical activity level Pre, mid and post study
Secondary Rating of perceived exertion during a stepping task Pre, mid and post study
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