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

Healthy Clinical Trial

— NATRITRAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519764
• Other study ID #: LOCAL/2015/OM-01
• Secondary ID: 2015-A00675-44
• Status: Completed
• Phase: N/A
• First received: August 7, 2015
• Last updated: September 1, 2015
• Start date: August 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Athletes
• Healthy

Intervention

Other:
• Hydration when thirsty.
Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt.
• Not hydration when thirsty
Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a "hydration when thirsty" protocol.

Locations

Country	Name	City	State
France	CHU de Nice - Hôpital St-Roch	Nice Cedex 1
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	DOKEVER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natremia (mmol/L)		Baseline	No
Primary	Natremia (mmol/L)		at finish, Days 0 to 2	No
Secondary	Weight (kg)		Baseline	No
Secondary	Weight (kg)		at finish, Days 0 to 2	No
Secondary	What year did you first start running regularly?	(pre-race questionnaire)	Baseline	No
Secondary	What year did you first start running ultra-trail races?	(pre-race questionnaire)	Baseline	No
Secondary	How many 100 miles or Ultra-trails races have you completed?	(pre-race questionnaire)	Baseline	No
Secondary	How many 100 miles or Ultra-trails races have you started but not finished?	(pre-race questionnaire)	Baseline	No
Secondary	What was your AVERAGE WEEKLY running training distance during the 3 months before the UTMB?	(pre-race questionnaire)	Baseline	No
Secondary	What was your HIGHEST running training distance IN ONE WEEK during the 3 months before the UTMB?	(pre-race questionnaire)	Baseline	No
Secondary	What was your LONGEST race or training run during the 3 months before the UTMB?	(pre-race questionnaire)	Baseline	No
Secondary	If you regularly take any medications, please list those here :	(pre-race questionnaire)	Baseline	No
Secondary	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	No
Secondary	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	No
Secondary	Indicate if you plan to use sodium supplements: yes/no	(pre-race questionnaire)	Baseline	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Did gastrointestinal (GI) symptoms affect your race performance? yes/no	(post-race questionnaire)	after race, days 0 to 2	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Urge to defecate IN THE PAST (PRIOR TO UTMB) WHILE RUNNING?		after race, days 0 to 2	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Have you had muscle cramps during prior ultra-trail runs? yes/no	(post-race questionnaire)	after race, days 0 to 2	No