Home » Trials » SLCTR/2012/012
Randomized controlled trial comparing rehydration with a commercially prepared energy drink, king-coconut water, tender coconut water and oral rehydration fluid among athletes
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SLCTR Registration Number
SLCTR/2012/012
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Randomized controlled trial comparing rehydration with a commercially prepared energy drink, king-coconut water, tender coconut water and oral rehydration fluid among athletes
Public Title of Trial
Randomized controlled trial comparing rehydration with a commercially prepared energy drink, king-coconut water, tender coconut water and oral rehydration fluid among athletes
Disease or Health Condition(s) Studied
Hydration status
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P176/10/2012 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Is the rehydrating ability of a commercially prepared energy drink (Gatorade), king coconut water, tender coconut water, and oral rehydration fluid (Jeewani) the same?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Crossover
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
The study will have four arms for the different rehydration fluids. The same group of 20 athletes will be provided with the four different fluids on four different days during their training with four days of wash out time in between. They will perform their routine training under natural conditions, for one hour while the ambient temperature and humidity levels will be recorded.
Inclusion criteria
Male and female athletes training for 800m to 1500m events •Age 18-35 years
Exclusion criteria
Any athlete with a condition incapable of performing the routine work out
Primary outcome(s)
|
1.
Anthropometric variables : Body fat (%), BMI (kg/ m², Body Surface Area (m²), muscle mass (kg), fat mass (kg) |
[ At baseline ] |
|
2.
Haematological and Biochemical markers : Plasma osmolality, serum electrolytes (Na+, K+, Cl- ), haematocrit and Hb, random blood sugar , serum pyruvate |
[ At baseline and two hours after commencing the workout ] |
|
3.
Urine specific gravity |
[ At baseline and two hours after commencement ] |
|
4.
Urine output and fluid intake |
[ One hour after work out, after one hour rest and two hours rest ] |
|
5.
Blood pressure, oral temperature, pulse, respiratory rate, body weight |
[ At baseline, one hour after workout, after one hour rest and two hours rest ] |
|
6.
Haematological and Biochemical markers : Plasma osmolality, serum electrolytes (Na+, K+, Cl- ), haematocrit and Hb, random blood sugar , serum pyruvate |
[ At baseline and two hours after commencing the workout ] |
|
7.
Urine specific gravity |
[ At baseline and two hours after commencement ] |
|
8.
Urine output and fluid intake |
[ One hour after work out, after one hour rest and two hours rest ] |
|
9.
Blood pressure, oral temperature, pulse, respiratory rate, body weight |
[ At baseline, one hour after workout, after one hour rest and two hours rest ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
20 middle distance athletes
Countries of recruitment
Sri Lanka
Anticipated start date
2012-12-01
Anticipated end date
2013-01-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Coconut Research Institue
Regulatory approvals
Status
Approved
Date of Approval
2012-10-17
Approval number
P176/10/2012
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. A. R. Wickremasinghe ,
Professor of Public Health
Faculty of Medicine Ragama, PO box 6, Thalagolla, Ragama, Sri lanka
+9411 961000
arwick@sltnet.lk
Contact Person for Public Queries
Dr. L. K. Athauda
Faculty of Medicine Ragama, PO box 6, Thalagolla, Ragama, Sri lanka
+94716845586
lathika.athauda@gmail.com
Primary study sponsor/organization
Coconut Research Institute .
Lunuwila, 61150, CRI
+94779801354
ejayamanne@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
