None listed
Conditions
Interventions
Intervention1: Test Electrolyte Drink - Variant 01: The electrolyte drinks (Sodium Chloride (0.26%), Potassium Chloride (0.15%), Ascorbic Acid (0.04%)) will be administered orally. Participants will c
Sponsors
Johnson & Johnson Pte Ltd.
JNTL Consumer Health India Pvt Ltd Kenvue India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Adults with age range more than or equal to 18 to less than or equal to 35 years old 3. Healthy participants with no known interfering,limiting conditions based on detailed medical history reported by the participants and as judged by the PI. 4. Body mass index: 18.5 to 22.9 kg per m2 5. Salivary osmolarity 66-100 mOsm for confirmation of dehydration after dehydration procedure on Day 2. 6. Body mass loss more than or equal to 1 percent for confirmation on dehydration status after dehydration procedure on Day 2. 7. Able to read, write, speak, and understand either English or Local languages. 8. Participant has signed and dated informed consent document before participating in any study specific procedures, indicating the participant has been informed of all pertinent aspects of the study. 9. Agree to restrict fluid and consume dry food alone for at least 24 hours. 10. Willing to remain in-house during the study period. 11. The participant is able to comprehend the requirements of the study based upon clinical site personnel assessment and is willing and able to comply with scheduled visits, tests, and other study procedures specified within the protocol.
Exclusion criteria
Exclusion criteria: 1. Participants following extreme dietary patterns (e.g., very low-fat or high-fat diets), specialized diets (such as ketogenic, paleo, or intermittent fasting), or those with evidence of disordered eating or intentional energy restriction within the last 1 month prior to screening. 2. Participants with any acute or chronic medical illness reported by the participants and as judged by the PI. 3. Participants using prescription or non-prescription medications at the time of inclusion that may interfere with hydration status, e.g., diuretics, cyclosporin, steroids or any other treatments that cannot be allowed in the study, in the opinion of the investigator. 4. Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including: Immunosuppressive or steroidal drugs within 2 months before Visit 1. * Non-steroidal anti-inflammatory drugs within 5 days before Visit 1. * Antihistamines within 2 weeks before Visit 1. Medications or supplements known to affect fluid or electrolyte balance or renal function (e.g., hormonal contraceptives, ayurvedic or herbal medications). * If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a participant begins using one of these medications during the study, the Study Physician/PI should be consulted to consider the impact of the specific medication on participants safety and/or the study results as described in Protocol Section 4.3 ( Concurrent/Concomitant Medication ). 5. Female participants who are pregnant or lactating or planning to become pregnant during the study. 6. Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual s participation in the study at discretion of PI. 7. Participants with insomnia or sleep problems or with any sleep-disrupting factors (e.g. shift work, recent trans meridian flight). 8. Female participants who are currently menstruating at the time of assessment. 9. Participants who are hypersensitive to any components of the electrolyte drinks and/or having allergy to food in diet plan. 10. Participant is related to persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees of Kenvue subsidiaries, contractors of Kenvue, and the families of each). 11. Participants who are participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first intake of study Investigational Product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of the electrolyte drinks in achieving the hydration status in dehydrated participants within 2 hours after electrolyte drinks consumption assessed by salivary osmolality.Timepoint: Beginning 10 minutes after electrolyte drinks administration and then at 5-minute intervals (at the following timepoints 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 min) until reaching the pre-defined euhydration threshold | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of the electrolyte drinks in improvement of hydration level in dehydrated participants within 1 hour after electrolyte drinks consumption assessed by subjective perception questionnaire.Timepoint: Assess perceived hydration status at baseline and every 10 mins (at the following timepoints: 10, 20, 30, 40, 50, 60 mins;To assess the effectiveness of the electrolyte drinks in improvement of hydration level in dehydrated participants within 2 hours after electrolyte drinks consumption assessed by subjective perception questionnaire.Timepoint: Assess perceived hydration status at baseline and every 10 mins (at the following timepoints: 10, 20, 30, 40, 50, 60, 75, 85, 95, 105, 120 mins | — |
Countries
India
Contacts
Public ContactDivya Purusothaman
JNTL Consumer Health India Private Limited Kenvue Brands LLC
Outcome results
None listed