Clinical trial NCT04460846: Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water.
Official title: Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water: A Randomized Controlled Cross-over Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blinded, placebo-controlled, cross-over trial
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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 criteria: 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.

Primary outcomes:
measure: Evaluation of hydration status using Bioelectrical Impedance Analysis
timeFrame: Change from baseline to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: