Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.