AzTrials
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HypoxiaNCT00731510

MEDEX Hidden Valley 2008

A study testing Carbohydrate energy drink and Aspartame in people with Hypoxia, run by Medical Expeditions Ltd at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypoxia
What is being tested?
Carbohydrate energy drink and Aspartame
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2008to Dec 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Persons with Phenylketonuria

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Medical Expeditions Ltd

    Pinfold, Hyssington, Montgomery, Powys, SY15 6AY

Other trials in United Kingdom

About this study

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.

Conditions
Hypoxia
Being tested
Carbohydrate energy drink, Aspartame
Keywords
Acute mountain sickness, Body composition,Hypoxia, Carbohydrate supplementation, Expedition,, Hydration,, Hypoxia, Performance
Medical subject headings
Hypoxia, Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carbohydrate energy drinkDietary supplement

    Also called PSP22 Energy, Science in Sport, Blackburn, UK

    Complex carbohydrates including maltodextrin (97%) dissolved in water to make a a 10% solution, or dissolved in 25mL gels. Ad libitum. Twenty two days.

  • AspartameDietary supplement

    Also called Science in Sport, Blackburn, UK

    Aspartame dissolved in water, ad libitum, 22 days.

Study groups in NCT00731510
Study groupRoleWhat they receive
1ExperimentalCarbohydrate supplements (drinks and gels)
Receives: Dietary Supplement: Carbohydrate energy drink
2Placebo comparatorPrimarily Aspartame plus natural flavourings. Powder dissolved in water to provide non-distinguishable placebo drink.
Receives: Dietary Supplement: Aspartame

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance (time to complete a physical performance task)

    Measured: Mid study

Secondary outcomes (7)

  1. Body composition

    Measured: Pre, mid and post study

  2. Hydration status

    Measured: Pre, mid and post study

  3. Body glucose stores

    Measured: Pre, mid and post study

  4. Oxygen delivery

    Measured: Pre, mid and post study

  5. Acute mountain sickness

    Measured: Every day

  6. Spontaneous physical activity level

    Measured: Pre, mid and post study

  7. Rating of perceived exertion during a stepping task

    Measured: Pre, mid and post study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionOct 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731510
Sponsor's protocol ID
08/WNo01/16
Status last verified
Mar 2017
First submitted
7 Aug 2008
Last updated
31 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19793859

Questions about this trial

What is this clinical trial studying?

A study testing Carbohydrate energy drink and Aspartame in people with Hypoxia, run by Medical Expeditions Ltd at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance (time to complete a physical performance task) (time frame: Mid study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00731510, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.

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