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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.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100617
Enrollment
525
Registered
2026-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Hydration Drink: Orange, Lemon, Peach, Green Apple, StrawberryKiwi, Mixed Berries flavoured drinks Control Intervention1: Packaged drinking water: Packaged drinking water

Sponsors

Bisleri International Pvt. Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 Timepoint: baseline to 15 min and 60 min post intervention.

Secondary

MeasureTime frame
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. Timepoint: baseline to 15 min and 60 min post intervention.

Countries

India

Contacts

Public ContactL Venkat Rangam

Medclinica

kiranmaigonugunta@gmail.com9441842632

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026