Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water: A Randomized Controlled Cross-over Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluation of hydration status using Bioelectrical Impedance Analysis
研究概览
简要总结
To conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population of chronically, moderately dehydrated people comparing two waters on hydration status.
详细描述
A randomized, double-blinded, placebo-controlled cross-over study design will be used to evaluate the effects of consumption of alkaline water against reverse osmosis water. The study is of 5 weeks' duration, with evaluation at baseline, 2 weeks (beginning of wash-out period), 3 weeks (end of wash-out period), and 5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult people of either gender;
- •Age 18 - 65 years (inclusive);
- •BMI between 18.0 and 34.9 (inclusive);
- •Screening results showing at least one of the following:
- •Hematocrit: Women: 45.0 or higher; Men: 48.7 or higher;
- •BUN/Creatinine ratio 20 or higher;
- •Sodium levels 146 mmol/L or higher;
- •Potassium levels 5.3 mmol/L or higher;
- •Chloride levels 108 mmol/L or higher.
- •Willing to maintain a consistent diet (including medications, vitamins and supplements) and lifestyle routine throughout the study;
- •Willing to abstain from coffee, tea, soft drinks, and nicotine for at least one hour prior to a clinic visit;
- •Willing to abstain from alcohol for at least 12 hours prior to a clinic visit;
- •Willing to maintain a consistent habit of abstaining from exercising and nutritional supplements on the morning of a study visit.
排除标准
- •Cancer during past 12 months;
- •Chemotherapy during past 12 months;
- •Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
- •Previous major surgery to stomach or intestines [(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal];
- •Implanted electronic device such as pacemaker or implantable cardioverter-defibrillator (ICD);
- •Currently experiencing peripheral edema in legs and /or feet;
- •Diagnosed with any blood clotting disorder or taking clotting factor concentrates;
- •Diagnosis of Peripheral Artery Disease;
- •Diagnosis of varicose veins;
- •Currently taking blood pressure medication;
- •Currently taking blood thinning medication (81mg aspirin allowed);
- •Currently taking diuretic medication;
- •Currently taking nutritional supplements and other substances judged by the study coordinator to negate or camouflage the effects of the test product;
- •Women who are pregnant, nursing, or trying to become pregnant.
研究组 & 干预措施
Alkaline water
Participants will consume 1.5 liters per day
干预措施: Alkaline water (Dietary Supplement)
Reverse osmosis water
Participants will consume 1.5 liters per day
干预措施: Reverse osmosis water (Dietary Supplement)
结局指标
主要结局
Evaluation of hydration status using Bioelectrical Impedance Analysis
时间窗: Change from baseline to 2 weeks
Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water.
次要结局
未报告次要终点