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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hydration

Intervention / Treatment
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* Dietary Supplement: Alkaline water
* Dietary Supplement: Reverse osmosis water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, double-blinded, placebo-controlled, cross-over trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alkaline water<br>Participants will consume 1.5 liters per day | Dietary Supplement: Alkaline water<br>* 1.5 liters per day<br>|
| Placebo Comparator: Reverse osmosis water<br>Participants will consume 1.5 liters per day | Dietary Supplement: Reverse osmosis water<br>* 1.5 liters per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of hydration status using Bioelectrical Impedance Analysis | Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water. | Change from baseline to 2 weeks |