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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Healthy; Athletes

Treatments: Other: Hydration when thirsty.; Other: Not hydration when thirsty

Study type: Interventional

Funder types: Other

Identifiers

NCT02519764

LOCAL/2015/OM-01

2015-A00675-44 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

Hydration when thirsty

Experimental group

Description:

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

Treatment:

Other: Hydration when thirsty.

Not hydration when thirsty

Experimental group

Description:

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

Treatment:

Other: Not hydration when thirsty