MEDEX Hidden Valley 2008
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 7, 2008
CompletedFirst Posted
Study publicly available on registry
August 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMarch 31, 2017
March 1, 2017
4 months
August 7, 2008
March 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance (time to complete a physical performance task)
Mid study
Secondary Outcomes (7)
Body composition
Pre, mid and post study
Hydration status
Pre, mid and post study
Body glucose stores
Pre, mid and post study
Oxygen delivery
Pre, mid and post study
Acute mountain sickness
Every day
- +2 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALCarbohydrate supplements (drinks and gels)
2
PLACEBO COMPARATORPrimarily Aspartame plus natural flavourings. Powder dissolved in water to provide non-distinguishable placebo drink.
Interventions
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 dissolved in water, ad libitum, 22 days.
Eligibility Criteria
You may qualify if:
- a healthy enthusiasm for the outdoors and/or a passion for research in remote and difficult circumstances
You may not qualify if:
- Persons with Phenylketonuria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical Expeditions Ltdlead
- Bangor Universitycollaborator
- Science in Sportcollaborator
- Plans Branch of Headquarters Army Recruiting and Training Divisioncollaborator
Study Sites (1)
Medical Expeditions Ltd
Pinfold, Hyssington, Montgomery, Powys, SY15 6AY, United Kingdom
Related Publications (1)
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.
PMID: 19793859DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie H Macdonald, PhD
Bangor University
- PRINCIPAL INVESTIGATOR
Samuel J Oliver, PhD
Bangor University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2008
First Posted
August 11, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
March 31, 2017
Record last verified: 2017-03