MEDEX Hidden Valley 2008

March 30, 2017 updated by: Medical Expeditions Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Powys
      • Pinfold, Hyssington, Montgomery, Powys, United Kingdom, SY15 6AY
        • Medical Expeditions Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Science in Sport, Blackburn, UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance (time to complete a physical performance task)
Time Frame: Mid study
Mid study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Expeditions Ltd

Collaborators

Bangor University
Science in Sport
Plans Branch of Headquarters Army Recruiting and Training Division

Investigators

  • Principal Investigator: Samuel J Oliver, PhD, Bangor University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/WNo01/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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