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CTRI Number  CTRI/2026/01/100617 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to determine if flavoured hydration drinks containing electrolytes are more effective than packaged drinking water in improving recovery from dehydration and electrolyte loss due to mild to moderate exercise in healthy adults. 
Scientific Title of Study   A Two-Part, Prospective,Open-Label, Parallel, Randomized, Comparative Clinical Study to Evaluate the Effects of Flavoured Electrolyte and Nutrient Hydration Drinks (Ready to serve, under FSSAI standard 2.3.10, Food category 14.1.4.2 ready to serve fruit beverages). Relative to Packaged Drinking (FSSAI standard no.2.10.8/Food Category 14.1.1.1) Water on Maintaining Fluid and Serum Electrolyte Balance Post Mild to Moderate Exercise in Healthy Adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CPBSHD00125 version 1.0 19 Dec 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shravan Kumar Ankathi 
Designation  Senior Consultant  
Affiliation  St Anns General and Cancer Hospital 
Address  St Anns General and Cancer Hospital, Fathimanagar, Kazipet, Warangal, Telangana, India- 506004.

Warangal
TELANGANA
506004
India 
Phone  9985579753  
Fax    
Email  drshravanankathi.krcwgl@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T Kiranmai  
Designation  CRA 
Affiliation  Medclinica 
Address  Corporate office MedClinica Private Limited #503, 5th Floor, Manjeera Majestic Commercial, Hitech City Road, Hyderabad

Hyderabad
TELANGANA
500072
India 
Phone  9441842632  
Fax    
Email  kiranmaigonugunta@gmail.com  
 
Details of Contact Person
Public Query  
Name  L Venkat Rangam 
Designation  Director 
Affiliation  Medclinica 
Address  Corporate office MedClinica Private Limited #503, 5th Floor, Manjeera Majestic Commercial, Hitech City Road, Hyderabad

Hyderabad
TELANGANA
500072
India 
Phone  9731753272  
Fax    
Email  venkat.rangam@gmail.com  
 
Source of Monetary or Material Support  
Bisleri International Pvt. Ltd,Sponsor 
 
Primary Sponsor  
Name  Bisleri International Pvt. Ltd 
Address  CTS No. 5251A1A,5th floor Western Express Highway, Opp Hindustan Unilever, at Chakala Division, Andheri (East), Mumbai - 400 099 India.  
Type of Sponsor  Other [Non Pharmaceutical company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avirath Anand Acchammachary   Silver Birch Multispecialty Hospital  Silver Birch Multispeciality Hospital, S.no.6/1A/9/20/10/11, UPD construction, near sawatamali mandir, Narhe -Dhayari road, Pune, Maharashtra -411041
Pune
MAHARASHTRA 		 9503607631

avirathacchammachary@gmail.com 
Dr Shravan Kumar Ankathi  St.Anns General & Cancer Hospital  St Anns General and Cancer Hospital, Fathimanagar, Kazipet, Warangal, Telangana, India- 506004
Warangal
TELANGANA 		 9985579753

drshravanankathi.krcwgl@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Central Independent Ethics Committee  Approved 
St.Anns Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hydration Drink  Orange, Lemon, Peach, Green Apple, StrawberryKiwi, Mixed Berries flavoured drinks 
Comparator Agent  Packaged drinking water  Packaged drinking water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Willingness to provide written informed consent to participate in the study.
2.Body mass index of greater than or equal 18.5kg per m2 and less than or equal 29.9 kg per m2(not obese), with body weight not less than 50 kg.
3. Clinically healthy status confirmed through medical history, physical examination and baseline laboratory evaluations.
4. Resting heart rate less than 90 beats per minute
5.Not hypertensive (systolic less than 140mmHg and Diastolic less than 90mmHg)
6.Normal baseline levels of serum electrolytes as determined by screening assessments.
7. will not consume caffeine containing beverages within 12 hours of testing
8. Ability and willing ness to abstain from alcohol from 48 hours prior to the study initiation until after completion of the study.
9. Willingness to refrain consuming any beverage during the assessment period
10.No participation in any other clinical trial within 30 days prior to study enrolment.




 
 
ExclusionCriteria 
Details  1.If female, lactating or pregnant women, who is planning to become pregnant during the study.
2.Have a known sensitivity or allergy to any of the study products.
3.Have a history of diabetes.
4.Have a history of known cardiovascular disease
5.Have an active or uncontrolled disease or conditions.
6.Have a history of a diagnosis of celiac disease, chronic pancreatitis,stearrhea,unstable thyroid disease, immune disorder (i.e. HIV or AIDS), cancer (within 5 years prior to screening visit)
7.Concomitant diseases (i.e. cancer, kidney diseases gastritis psychiatric diseases, blood disorders, Gastrointestinal diseases).
8.Current smokers or history of significant smoking (greater than 10 cigarettes per day)
9.Any weight loss medications (including alternative medication products) within 90 days prior to study.



 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Mean Change in serum electrolyte levels (e.g., sodium, potassium) from baseline to 15 min and 60 min post-intervention.
2.Mean change in Urine specific gravity, from baseline to 15 min and 60 min post intervention.
3.Change in self-reported thirst perception score from baseline to 15 min and 60 min post-intervention, as measured by a 5-point Likert scale
 		 baseline to 15 min and 60 min post intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean change in Urine output in mL, from base to 60min post intervention
2.Percentage change or mean change in body mass in kg, from baseline to 15min and 60min post intervention.
3.Change in mean sensory attribute (Palatability, smell, texture, mouthfeel and after taste) scores from 15 min to 60 min post-intervention, as measured by participant ratings on a 5-point Likert scale.
4.Safety and tolerability throughout study period.
 		 baseline to 15 min and 60 min post intervention. 
 
Target Sample Size   Total Sample Size="525"
Sample Size from India="525" 
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   N/A 
Date of First Enrollment (India)   19/01/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a two-part, prospective, open-label, randomized, parallel-group, multi-centre study in 525 healthy adults to evaluate the effects of flavoured hydration drinks compared with packaged drinking water on fluid and serum electrolyte balance following mild to moderate exercise. Participants will undergo a standardized 60-minute treadmill exercise followed by consumption of the assigned beverage using an individualized fluid replacement method. Primary outcomes include changes in serum electrolytes, urine specific gravity, and thirst perception at 15- and 60-minutes post-intervention. Secondary outcomes include urine output, body mass change, sensory evaluation, and safety.

 
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