MEDEX Hidden Valley 2008

NCT ID: NCT00731510

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Carbohydrate supplements (drinks and gels)

Group Type EXPERIMENTAL

Carbohydrate energy drink

Intervention Type DIETARY_SUPPLEMENT

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

2

Primarily Aspartame plus natural flavourings. Powder dissolved in water to provide non-distinguishable placebo drink.

Group Type PLACEBO_COMPARATOR

Aspartame

Intervention Type DIETARY_SUPPLEMENT

Aspartame dissolved in water, ad libitum, 22 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Aspartame

Aspartame dissolved in water, ad libitum, 22 days.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Persons with Phenylketonuria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bangor University

OTHER

Sponsor Role collaborator

Science in Sport

UNKNOWN

Sponsor Role collaborator

Plans Branch of Headquarters Army Recruiting and Training Division

UNKNOWN

Sponsor Role collaborator

Medical Expeditions Ltd

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jamie H Macdonald, PhD

Role: PRINCIPAL_INVESTIGATOR

Bangor University

Samuel J Oliver, PhD

Role: PRINCIPAL_INVESTIGATOR

Bangor University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Expeditions Ltd

Pinfold, Hyssington, Montgomery, Powys, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 19793859 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08/WNo01/16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Hyperbaric Oxygen Therapy
NCT06112210 COMPLETED NA
Lyske Trial (Danish) Groin Trial
NCT00226603 UNKNOWN PHASE2/PHASE3