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MEDEX Hidden Valley 2008

This study has been completed.
Sponsor:
Collaborators:
Bangor University
Science in Sport
Plans Branch of Headquarters Army Recruiting and Training Division
Information provided by (Responsible Party):
Medical Expeditions Ltd
ClinicalTrials.gov Identifier:
NCT00731510
First received: August 7, 2008
Last updated: March 30, 2017
Last verified: March 2017
  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
Hypoxia
Dietary Supplement: Carbohydrate energy drink
Dietary Supplement: Aspartame

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Other
Official Title: MEDEX Hidden Valley 2008

Resource links provided by NLM:


Further study details as provided by Medical Expeditions Ltd:

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

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

Enrollment: 44
Study Start Date: June 2008
Study Completion Date: December 2008
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Study First Received: August 7, 2008
Last Updated: March 30, 2017

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 25, 2017