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CTRI Number  CTRI/2019/07/020285 [Registered on: 19/07/2019] Trial Registered Prospectively
Last Modified On: 18/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Epidemiological]  
Study Design  Other 
Public Title of Study   Measure of Hydration status and Sweat loss during sport performance, its relationship with Nutritional status and Hydration Knowledge, Attitude and Practice among Young sportsperson. 
Scientific Title of Study   Hydration status and Sweat loss estimation during athletic performance, its association with Nutritional status and Hydration Knowledge, Attitude and Practice among Young athletes.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mridul Soni 
Designation  Student  
Affiliation  Welcomegroup Graduate School of Hotel Administration 
Address  Department of Dietetics and Applied Nutrition Welcomegroup Graduate School of Hotel Administration Manipal Academy of Higher Education Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  8769072854  
Fax    
Email  Mridulsoni14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Namratha N Pai 
Designation  Assistant Professor  
Affiliation  Welcomegroup Graduate School of Hotel Administration  
Address  Department of Dietetics and Applied Nutrition Welcomegroup Graduate School of Hotel Administration Manipal Academy of Higher Education Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  9945305773  
Fax    
Email  namratha.npai@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mahjabin 
Designation  Student 
Affiliation  Welcomegroup Graduate School of Hotel Administration  
Address  Department of Dietetics and Applied Nutrition Welcomegroup Graduate School of Hotel Administration Manipal Academy of Higher Education Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  8875511960  
Fax    
Email  Qureshimahjabin@gmail.com  
 
Source of Monetary or Material Support  
Mrs. Namratha N Pai,Assistant professor, M.Sc. Dietetics and Applied Nutrition Department of Allied Hospitality Studies WGSHA, MAHE, Manipal 576104, Karnataka 
 
Primary Sponsor  
Name  Mridul Soni 
Address  Welcomegroup Graduate School of Hotel Management 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mridul Soni   Ajjarakadu Mahatma Gandhi District Stadium  Youth Empowerment and Sports Department Brahmagiri, Udupi
Udupi
KARNATAKA 		 8769072854

mridulsoni14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No co-morbid disease or illness  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hydration and Nutrition Education  education material will be given to the subjects after the collection of data. 
Comparator Agent  Hydration Knowledge, Attitude and practice, sweat loss estimation and nutrition status  Data will be collected by using a semi structured validated Hydration Knowledge, Attitude and Practice Questionnaire, 24 hr Home Recall, Food Frequency Questionnaire, Modified Kuppuswamy scale(2018), Urine color chart, Anthropometric assessment and Queens college Step Test for athletic performance. The participants will be asked to maintain a 1 litre water bottle for 24 hrs to check the fluid intake. The pre and post training weight will be taken into consideration along with 24 hr water consumption to estimate the sweat loss.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  29.00 Year(s)
Gender  Both 
Details  Athletes who practice 4-5 hrs per week.
Athletes who do not have any co-morbid condition  
 
ExclusionCriteria 
Details  Athletes having any co-morbid conditions or illness.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the Hydration status and Sweat loss estimation during athletic performance.   First visit 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the perceived and measured fluid intake.   Second Visit 
To associate Hydration Knowledge, Attitude and Practice with Hydration Status  Third visit 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   25/07/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Knowledge and use of hydration strategies has been shown to enhance hydration status, thereby suggesting that education and utilization of hydration strategies could be a potential tool to improve the hydration status of athletes. So the study will help in identifying the specific areas of education by assessing the knowledge, attitude and practice in athletes related to their fluid intake and hydration status. How to incorporate the knowledge into their regular training and lifestyle will be explained so that certain myths and misconceptions can be cleared out. Nutrition education on Fluid intake and Hydration status will make the training performance of athletes better.   
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