Clinical trial NCT02519764: Evaluation of the Impact of a Hydration Protocol "at Thirst" on Natremia of the Ultra Trail du Mont-Blanc, 2015 Runners
Official title: Evaluation of the Impact of a Hydration Protocol "at Thirst" on Natremia of the Ultra Trail du Mont-Blanc, 2015 Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletes
Healthy
Keywords: volunteer runners who are participating in the 2015 Mont Blanc Ultra Trail
hydration protocol
natremia
Volunteers
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: DOKEVER
First posted: 2015-08-11
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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).

Primary outcomes:
measure: Natremia (mmol/L)
timeFrame: Baseline
measure: Natremia (mmol/L)
timeFrame: at finish, Days 0 to 2
Secondary outcomes:
measure: Weight (kg)
timeFrame: Baseline
measure: Weight (kg)
timeFrame: at finish, Days 0 to 2
measure: What year did you first start running regularly?
timeFrame: Baseline
measure: What year did you first start running ultra-trail races?
timeFrame: Baseline
measure: How many 100 miles or Ultra-trails races have you completed?
timeFrame: Baseline
measure: How many 100 miles or Ultra-trails races have you started but not finished?
timeFrame: Baseline
measure: What was your AVERAGE WEEKLY running training distance during the 3 months before the UTMB?
timeFrame: Baseline
measure: What was your HIGHEST running training distance IN ONE WEEK during the 3 months before the UTMB?
timeFrame: Baseline
measure: What was your LONGEST race or training run during the 3 months before the UTMB?
timeFrame: Baseline
measure: If you regularly take any medications, please list those here :
timeFrame: Baseline
measure: What were the main factors you used to decide how much to drink during the race?
timeFrame: Baseline
measure: What will you primarily drink during the race?
timeFrame: before start of race, day -1
measure: Indicate if you plan to use sodium supplements: yes/no
timeFrame: Baseline
measure: What is the estimated number of sodium supplements you plan to use during the race?
timeFrame: Baseline
measure: Reflux/heartburn BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Bloating BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Stomach cramps/pain BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Nausea BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Vomiting BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Intestinal cramps/pain BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Flatulence BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Side ache/stitch BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Urge to defecate BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Loose stool/diarrhea BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Intestinal bleeding/bloody feces BEFORE THE START OF THE RACE ?
timeFrame: after race, days 0 to 2
measure: Reflux/heartburn FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Bloating FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Stomach cramps/pain FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Nausea FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Vomiting FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Intestinal cramps/pain FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Flatulence FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Side ache/stitch FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Urge to defecate FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Loose stool/diarrhea FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Intestinal bleeding/bloody feces FROM THE START TO COURMAYEUR ?
timeFrame: after race, days 0 to 2
measure: Reflux/heartburn FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Bloating FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Stomach cramps/pain FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Nausea FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Vomiting FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Intestinal cramps/pain FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Flatulence FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Side ache/stitch FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Urge to defecate FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Loose stool/diarrhea FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Intestinal bleeding/bloody feces FROM COURMAYEUR TO CHAMONIX ?
timeFrame: after race, days 0 to 2
measure: Did gastrointestinal (GI) symptoms affect your race performance? yes/no
timeFrame: after race, days 0 to 2
measure: Reflux/heartburn IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Bloating IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Stomach cramps/pain IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Nausea IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Vomiting IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Intestinal cramps/pain IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Flatulence IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Side ache/stitch IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Urge to defecate IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Loose stool/diarrhea IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Intestinal bleeding/bloody feces IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?
timeFrame: after race, days 0 to 2
measure: Did you use any medications (including prescription and over-the-counter) immediately before or during the 2015 UTMB? (post-race questionnaire)
timeFrame: after race, days 0 to 2
measure: Did you have any muscle cramps during the 2015 UTMB?
timeFrame: after race, days 0 to 2
measure: If yes, In which muscles did you have an issue with cramping during the 2015 UTMB?
timeFrame: after race, days 0 to 2
measure: If yes, Indicate which race section(s) you had issues with muscle cramps (post-race questionnaire)
timeFrame: after race, days 0 to 2
measure: Have you had muscle cramps during prior ultra-trail runs? yes/no
timeFrame: after race, days 0 to 2
Other outcomes:
Locations:
city: Nice Cedex 1
country: France
facility: CHU de Nice - Hôpital St-Roch
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Olivier Marès, MD
role: STUDY_DIRECTOR
References: