Evaluation of the Impact of a Hydration Protocol "at Thirst" on Natremia of the Ultra Trail du Mont-Blanc, 2015 Runners

NCT ID: NCT02519764

Last Updated: 2025-11-19

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-08-30

Brief Summary

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The main objective of this study is to evaluate the impact of a hydration protocol "at thirst" compared to other "not at thirst" hydration protocols on the changes in serum sodium in runners of the Ultra Trail Mont-Blanc (UTMB) in 2015.

Detailed Description

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The secondary objectives of this study are:

A. To assess the relationship between hydration protocols and the dropout rate. B. To evaluate the correlation between body weight change before and after the race and serum sodium before and after the race.

C. To evaluate the change in serum sodium into major types of conventional hydration protocols.

D. To evaluate the incidence of adverse events (cramps, gastrointestinal symptoms, etc ...) depending on the hydration protocol and the serum sodium.

Conditions

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Athletes Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Hydration when thirsty

Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt.

Group Type EXPERIMENTAL

Hydration when thirsty.

Intervention Type OTHER

Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt.

Not hydration when thirsty

Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a "hydration when thirsty" protocol.

Group Type EXPERIMENTAL

Not hydration when thirsty

Intervention Type OTHER

Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a "hydration when thirsty" protocol.

Interventions

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Hydration when thirsty.

Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt.

Intervention Type OTHER

Not hydration when thirsty

Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a "hydration when thirsty" protocol.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The subject must have given his/her informed and signed consent
* The subject must be insured or beneficiary of a health insurance plan
* The subject is participating in the 2015 Mont-Blanc Ultra Trail and has no contra-indication for ultra-trail activities

Exclusion Criteria

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The subject is under judicial protection, under tutorship or curatorship
* The subject refuses to sign the consent
* It is impossible to correctly inform the subject
* The subject is pregnant or breastfeeding

The subject will be excluded from the study in case of early drop out (before 15 km of trail).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DOKEVER

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Marès, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nice - Hôpital St-Roch

Nice, , France

Site Status

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

References

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Mouzat K, Raoul C, Polge A, Kantar J, Camu W, Lumbroso S. Liver X receptors: from cholesterol regulation to neuroprotection-a new barrier against neurodegeneration in amyotrophic lateral sclerosis? Cell Mol Life Sci. 2016 Oct;73(20):3801-8. doi: 10.1007/s00018-016-2330-y. Epub 2016 Aug 10.

Reference Type RESULT
PMID: 27510420 (View on PubMed)

Other Identifiers

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2015-A00675-44

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2015/OM-01

Identifier Type: -

Identifier Source: org_study_id

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