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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Natural Immune Systems Inc
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Updated on 19 February 2024
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Summary

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.

Details
Condition Hydration
Age 18years - 65years
Treatment Alkaline water, Reverse osmosis water
Clinical Study IdentifierNCT04460846
SponsorNatural Immune Systems Inc
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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