Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water.

Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water: A Randomized Controlled Cross-over Pilot Study

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.

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.

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.