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

Study Overview
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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.

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

Conditions
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Athletes, Healthy

Intervention / Treatment
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* Other: Hydration when thirsty.
* Other: Not hydration when thirsty


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydration when thirsty<br>Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt. | Other: Hydration when thirsty.<br>* Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt.<br>|
| Experimental: Not hydration when thirsty<br>Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a hydration when thirsty protocol. | Other: Not hydration when thirsty<br>* Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a hydration when thirsty protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natremia (mmol/L) |  | Baseline | 
| Natremia (mmol/L) |  | at finish, Days 0 to 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) |  | Baseline | 
| Weight (kg) |  | at finish, Days 0 to 2 | 
| What year did you first start running regularly? | (pre-race questionnaire) | Baseline | 
| What year did you first start running ultra-trail races? | (pre-race questionnaire) | Baseline | 
| How many 100 miles or Ultra-trails races have you completed? | (pre-race questionnaire) | Baseline | 
| How many 100 miles or Ultra-trails races have you started but not finished? | (pre-race questionnaire) | Baseline | 
| What was your AVERAGE WEEKLY running training distance during the 3 months before the UTMB? | (pre-race questionnaire) | Baseline | 
| What was your HIGHEST running training distance IN ONE WEEK during the 3 months before the UTMB? | (pre-race questionnaire) | Baseline | 
| What was your LONGEST race or training run during the 3 months before the UTMB? | (pre-race questionnaire) | Baseline | 
| If you regularly take any medications, please list those here : | (pre-race questionnaire) | 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) | 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) | before start of race, day -1 | 
| Indicate if you plan to use sodium supplements: yes/no | (pre-race questionnaire) | 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) | 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) | after race, days 0 to 2 | 
| Bloating 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) | after race, days 0 to 2 | 
| Stomach cramps/pain 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) | after race, days 0 to 2 | 
| Nausea 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) | after race, days 0 to 2 | 
| Vomiting 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) | after race, days 0 to 2 | 
| Intestinal cramps/pain 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) | after race, days 0 to 2 | 
| Flatulence 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) | after race, days 0 to 2 | 
| Side ache/stitch 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) | after race, days 0 to 2 | 
| Urge to defecate 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) | after race, days 0 to 2 | 
| Loose stool/diarrhea 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) | after race, days 0 to 2 | 
| Intestinal bleeding/bloody feces 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) | after race, days 0 to 2 | 
| Reflux/heartburn FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Bloating FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Stomach cramps/pain FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Nausea FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Vomiting FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Intestinal cramps/pain FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Flatulence FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Side ache/stitch FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Urge to defecate FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Loose stool/diarrhea FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Intestinal bleeding/bloody feces FROM THE START TO COURMAYEUR ? | What GI symptoms did you experience… FROM THE START TO COURMAYEUR ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Reflux/heartburn FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Bloating FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Stomach cramps/pain FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Nausea FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Vomiting FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Intestinal cramps/pain FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Flatulence FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Side ache/stitch FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Urge to defecate FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Loose stool/diarrhea FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Intestinal bleeding/bloody feces FROM COURMAYEUR TO CHAMONIX ? | What GI symptoms did you experience… FROM COURMAYEUR TO CHAMONIX ? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Did gastrointestinal (GI) symptoms affect your race performance? yes/no | (post-race questionnaire) | after race, days 0 to 2 | 
| Reflux/heartburn IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Bloating IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Stomach cramps/pain IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Nausea IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Vomiting IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Intestinal cramps/pain IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Flatulence IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Side ache/stitch IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | 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? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | after race, days 0 to 2 | 
| Intestinal bleeding/bloody feces IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? | What GI symptoms did you experience… IN THE PAST (PRIOR TO UTMB) WHILE RUNNING? Please mark the severity of each symptom using the scale of None, Mild, Moderate, Severe, or Very Severe (post-race questionnaire) | 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) | If so, please list | after race, days 0 to 2 | 
| Did you have any muscle cramps during the 2015 UTMB? | Yes Almost, but was able to control any full-blown cramping No (post-race questionnaire) | after race, days 0 to 2 | 
| If yes, In which muscles did you have an issue with cramping during the 2015 UTMB? | Calf muscles Quadriceps Hamstrings Hip flexors (muscles in front of pelvis and top of leg) Other(s) (please specify): ____________________ (post-race questionnaire) | after race, days 0 to 2 | 
| If yes, Indicate which race section(s) you had issues with muscle cramps (post-race questionnaire) | Start to Courmayeur Courmayeur to Chamonix (post-race questionnaire) | after race, days 0 to 2 | 
| Have you had muscle cramps during prior ultra-trail runs? yes/no | (post-race questionnaire) | after race, days 0 to 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteer runners who are participating in the 2015 Mont Blanc Ultra Trail, hydration protocol, natremia, Volunteers