Back to resultsMEDEX Hidden Valley 2008
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Carbohydrate energy drink
Aspartame
Sponsored by
About this trial
This is an interventional other trial for Hypoxia focused on measuring Acute mountain sickness, Body composition,Hypoxia, Carbohydrate supplementation, Expedition,, Hydration,, Hypoxia, Performance
Eligibility 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
Sites / Locations
- Medical Expeditions Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Carbohydrate supplements (drinks and gels)
Primarily Aspartame plus natural flavourings. Powder dissolved in water to provide non-distinguishable placebo drink.
Outcomes
Primary Outcome Measures
Performance (time to complete a physical performance task)
Secondary Outcome Measures
Body composition
Hydration status
Body glucose stores
Oxygen delivery
Acute mountain sickness
Spontaneous physical activity level
Rating of perceived exertion during a stepping task
Full Information
NCT ID
NCT00731510
First Posted
August 7, 2008
Last Updated
March 30, 2017
Sponsor
Medical Expeditions Ltd
Collaborators
Bangor University, Science in Sport, Plans Branch of Headquarters Army Recruiting and Training Division
1. Study Identification
Unique Protocol Identification Number
NCT00731510
Brief Title
MEDEX Hidden Valley 2008
Official Title
MEDEX Hidden Valley 2008
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Expeditions Ltd
Collaborators
Bangor University, Science in Sport, Plans Branch of Headquarters Army Recruiting and Training Division
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
Acute mountain sickness, Body composition,Hypoxia, Carbohydrate supplementation, Expedition,, Hydration,, Hypoxia, Performance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Carbohydrate supplements (drinks and gels)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Primarily Aspartame plus natural flavourings. Powder dissolved in water to provide non-distinguishable placebo drink.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate energy drink
Other Intervention Name(s)
PSP22 Energy, Science in Sport, Blackburn, UK
Intervention Description
Complex carbohydrates including maltodextrin (97%) dissolved in water to make a a 10% solution, or dissolved in 25mL gels. Ad libitum. Twenty two days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Aspartame
Other Intervention Name(s)
Science in Sport, Blackburn, UK
Intervention Description
Aspartame dissolved in water, ad libitum, 22 days.
Primary Outcome Measure Information:
Title
Performance (time to complete a physical performance task)
Time Frame
Mid study
Secondary Outcome Measure Information:
Title
Body composition
Time Frame
Pre, mid and post study
Title
Hydration status
Time Frame
Pre, mid and post study
Title
Body glucose stores
Time Frame
Pre, mid and post study
Title
Oxygen delivery
Time Frame
Pre, mid and post study
Title
Acute mountain sickness
Time Frame
Every day
Title
Spontaneous physical activity level
Time Frame
Pre, mid and post study
Title
Rating of perceived exertion during a stepping task
Time Frame
Pre, mid and post study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie H Macdonald, PhD
Organizational Affiliation
Bangor University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel J Oliver, PhD
Organizational Affiliation
Bangor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Expeditions Ltd
City
Pinfold, Hyssington, Montgomery
State/Province
Powys
ZIP/Postal Code
SY15 6AY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19793859
Citation
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.
Results Reference
derived
Learn more about this trial
MEDEX Hidden Valley 2008
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