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

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country198 target enrollmentAugust 1, 2015

ConditionsAthletes Healthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Athletes
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 198
Locations: 2
Primary Endpoint: Natremia (mmol/L)
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2015

End Date

August 30, 2015

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Natremia (mmol/L)

Time Frame: at finish, Days 0 to 2

Secondary Outcomes

What year did you first start running regularly?(Baseline)
What year did you first start running ultra-trail races?(Baseline)
Weight (kg)(at finish, Days 0 to 2)
How many 100 miles or Ultra-trails races have you completed?(Baseline)
How many 100 miles or Ultra-trails races have you started but not finished?(Baseline)
What was your AVERAGE WEEKLY running training distance during the 3 months before the UTMB?(Baseline)
What was your HIGHEST running training distance IN ONE WEEK during the 3 months before the UTMB?(Baseline)
What was your LONGEST race or training run during the 3 months before the UTMB?(Baseline)
If you regularly take any medications, please list those here :(Baseline)
What were the main factors you used to decide how much to drink during the race?(Baseline)
What will you primarily drink during the race?(before start of race, day -1)
Indicate if you plan to use sodium supplements: yes/no(Baseline)
What is the estimated number of sodium supplements you plan to use during the race?(Baseline)
Reflux/heartburn BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Nausea BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Vomiting BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Intestinal cramps/pain BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Bloating BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Stomach cramps/pain BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Flatulence BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Side ache/stitch BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Urge to defecate BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Loose stool/diarrhea BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Intestinal bleeding/bloody feces BEFORE THE START OF THE RACE ?(after race, days 0 to 2)
Reflux/heartburn FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Bloating FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Stomach cramps/pain FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Nausea FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Vomiting FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Intestinal cramps/pain FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Flatulence FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Side ache/stitch FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Urge to defecate FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Loose stool/diarrhea FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Intestinal bleeding/bloody feces FROM THE START TO COURMAYEUR ?(after race, days 0 to 2)
Reflux/heartburn FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Bloating FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Stomach cramps/pain FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Nausea FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Vomiting FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Intestinal cramps/pain FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Flatulence FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Side ache/stitch FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Urge to defecate FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Loose stool/diarrhea FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Intestinal bleeding/bloody feces FROM COURMAYEUR TO CHAMONIX ?(after race, days 0 to 2)
Did gastrointestinal (GI) symptoms affect your race performance? yes/no(after race, days 0 to 2)
Reflux/heartburn IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Bloating IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Stomach cramps/pain IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Nausea IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Vomiting IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Intestinal cramps/pain IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Flatulence IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Side ache/stitch IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Urge to defecate IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Loose stool/diarrhea IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Intestinal bleeding/bloody feces IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?(after race, days 0 to 2)
Did you use any medications (including prescription and over-the-counter) immediately before or during the 2015 UTMB? (post-race questionnaire)(after race, days 0 to 2)
Did you have any muscle cramps during the 2015 UTMB?(after race, days 0 to 2)
If yes, In which muscles did you have an issue with cramping during the 2015 UTMB?(after race, days 0 to 2)
If yes, Indicate which race section(s) you had issues with muscle cramps (post-race questionnaire)(after race, days 0 to 2)
Have you had muscle cramps during prior ultra-trail runs? yes/no(after race, days 0 to 2)