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

N/ACompletedNCT02519764

Centre Hospitalier Universitaire de Nīmes198 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

198

Conditions

Athletes Healthy

Interventions

Hydration when thirsty.OTHER

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

Not hydration when thirstyOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (2)

CHU de Nice - Hôpital St-Roch

Nice, France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

Natremia (mmol/L)

Time frame: Baseline

Natremia (mmol/L)

Time frame: at finish, Days 0 to 2

Secondary Outcomes

Weight (kg)

Time frame: Baseline

Weight (kg)

Time frame: at finish, Days 0 to 2

What year did you first start running regularly?

(pre-race questionnaire)

Time frame: Baseline

What year did you first start running ultra-trail races?

(pre-race questionnaire)

Time frame: Baseline

How many 100 miles or Ultra-trails races have you completed?

(pre-race questionnaire)

Time frame: Baseline

How many 100 miles or Ultra-trails races have you started but not finished?

(pre-race questionnaire)

Time frame: Baseline

What was your AVERAGE WEEKLY running training distance during the 3 months before the UTMB?

(pre-race questionnaire)

Time frame: Baseline

What was your HIGHEST running training distance IN ONE WEEK during the 3 months before the UTMB?

(pre-race questionnaire)

Time frame: Baseline

Data from ClinicalTrials.gov

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What was your LONGEST race or training run during the 3 months before the UTMB?

(pre-race questionnaire)

Time frame: Baseline

If you regularly take any medications, please list those here :

(pre-race questionnaire)

Time frame: Baseline

What were the main factors you used to decide how much to drink during the race?

(You may select more than one factor, but please be sure to select at least one factor.) Thirst(1) A pre-determined drinking schedule according to distance or time (2) The maximum amount I could tolerate (3) The amount of change in my body weight (4) My urine color (5) Other (please specify) (pre-race questionnaire)

Time frame: Baseline

What will you primarily drink during the race?

(Please select only one drink option.)? Water only (1) Mostly water and some electrolyte containing drink (2) About an equal amount of water and electrolyte containing drink (3) Mostly electrolyte containing drink and some water (4) Only electrolyte containing drink (5) Other (please specify): (6)

Time frame: before start of race, day -1

Indicate if you plan to use sodium supplements: yes/no

(pre-race questionnaire)

Time frame: Baseline

What is the estimated number of sodium supplements you plan to use during the race?

(Please only enter a number for the supplements you use. In other words, you do not need to enter a zero if you did not use the supplement.) Succeed S! Caps (1) Hammer Endurolyte Capsules (2) Hammer Endurolytes Fizz Tablets (3) SaltStick Caps (4) SaltStick Caps Plus (5) Nuun Electrolyte Enhanced Drink Tabs (6) GU Roctane Electrolyte Capsules (7) GU Brew Electrolyte Tablets (8) Lava Salts Capsules (9) Other (please specify) (10) Other (please specify) (10) Other (please specify) (10) (pre-race questionnaire)

Time frame: Baseline

Reflux/heartburn BEFORE THE START OF THE RACE ?

What GI symptoms did you experience… BEFORE THE START OF THE RACE ? Please mark the severity of each symptom using the scale of "None", "Mild", "Moderate", "Severe", or "Very Severe" (post-race questionnaire)