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

Completed · Not applicable · Has a placebo group

Conditions studied: Hydration

In brief

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.

Key facts

Study ID

NCT04460846

Run by

Natural Immune Systems Inc

People needed

12

Starts

2020-03-01

Expected to finish

2021-12-19

Last updated by the study team

2022-09-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NIS Labs — Klamath Falls, Oregon, United States

Full record on ClinicalTrials.gov

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