CTRI/2026/01/100617进行中（未招募）不适用
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.
Bisleri International Pvt. Ltd2 个研究点 分布在 1 个国家目标入组 525 人开始时间: 2026年1月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 525
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Clinically healthy status confirmed through medical history, physical examination and baseline laboratory evaluations.
- •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.
- •Ability and willing ness to abstain from alcohol from 48 hours prior to the study initiation until after completion of the study.
- •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.
排除标准
- •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.
研究者
Dr Shravan Kumar Ankathi
St Anns General and Cancer Hospital
研究点 (2)
Loading locations...
相似试验
招募中
3 期
Effectiveness of Injection Semaglutide in Overweight or ObesityCTRI/2025/07/092006Hetero Labs Limited258
已完成
4 期
To understand activity of formulation containing Lactoferrin cream and Luliconazole cream against Luliconazole Cream alone in treatment of skin fungal infectionsCTRI/2024/03/063840Frimline Private Limited60
进行中（未招募）
3 期
Polmacoxib and Paracetamol combination effectiveness in pain relief after dental extractionCTRI/2023/11/060049Hetero Labs Limited160
尚未招募
3 期
Use of Intravenous Tenecteplase in Participants with Acute Ischemic StrokeCTRI/2026/02/103867University of Calgary4,000
已完成
不适用
A multiple-dose BE study with clinical endpoint comparing Paliperidone Palmitate Prolonged Release suspension for injection 100 mg of Qilu Pharmaceuticals Co., Ltd with Xeplion Prolonged Release suspension for Injection 100 mg of Janssen-Cilag International NV in subjects with schizophrenia.CTRI/2024/11/077360Qilu Pharmaceuticals Co., Ltd.240