Effectiveness of Electrolyte Drinks in Restoring Hydration during Dehydration: A Multicentered, Open label, Prospective Clinical Study in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
研究概览
简要总结
This study designed to investigate the effectiveness of electrolyte drinks in restoring hydration in the dehydrated participants.
This is a multi-centered, open-label, interventional, prospective, clinical study of three variants of electrolyte drink in restoring hydration in dehydrated participants. A total of 90 healthy participants, including male and non-pregnant/ non-lactating female aged between 18 to 35 years (both inclusive) of age will be enrolled in the study. The potential participants will be screened based on the inclusion and exclusion criteria only after obtaining the written informed consent from the participants. Participants will be contacted telephonically by the recruiting/ screening department prior to the enrolment visit. Participants will be housed in a controlled environment maintained at a temperature of 23°C to 30°C and relative humidity of 40% RH to 60% RH.
The participants will be instructed to visit the facility as per the visits below:
Visit 1: Screening, ICD Obtained,
Visit 2:
Day 1: Participant**’**s reporting to facility in early morning, Euhydrated State Assessments and Dehydration Procedure, Day and Overnight housing.
Participants will undergo a 24-hour controlled fluid-restriction phase, during which total fluid intake will be 500 mL of water to induce dehydration while maintaining participant comfort.
Day 2: Dehydration Confirmation, Intervention Phase, Follow-up Assessments, and End-of-Study Procedures, Discharge from the facility
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and/or Female
- •Adults with age range more than or equal to 18 to less than or equal to 35 years old
- •Healthy participants with no known interfering/limiting conditions based on detailed medical history reported by the participants and as judged by the PI.
- •Body mass index (BMI): 18.5 to 22.9 kg/m2
- •Salivary osmolarity 66-100 mOsm for confirmation of dehydration after dehydration procedure on Day
- •Body mass loss more than or equal to 1% for confirmation on dehydration status after dehydration procedure on Day 2
- •Able to read, write, speak, and understand either English, Gujarati, Hindi, Telugu or Tamil languages.
- •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.
- •Agree to restrict fluid and consume dry food alone for at least 24 hours.
- •Willing to remain in-house during the study period.
- •The participant is able to comprehend the requirements of the study (based upon clinical site personnel’s assessment) and is willing and able to comply with scheduled visits, tests, and other study procedures specified within the protocol.
排除标准
- •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.
- •Participants with any acute or chronic medical illness reported by the participants and as judged by the PI.
- •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.
- •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
- •• Non-steroidal anti-inflammatory drugs within 5 days before Visit
- •• Antihistamines within 2 weeks before Visit
- •• medications or supplements known to affect fluid or electrolyte balance or renal function (e.g., hormonal contraceptives, ayurvedic or herbal medications).
- •Female participants who are pregnant or lactating or planning to become pregnant during the study.
- •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.
- •Participants with insomnia or sleep problems or with any sleep-disrupting factors (e.g. shift work, recent trans meridian flight).
- •Female participants who are currently menstruating at the time of assessment.
- •Participants who are hypersensitive to any components of the electrolyte drinks.
- •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).
- •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.
研究者
Dr Nayan Patel MBBS
NovoBliss Research Private Limited