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

Hydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460846
• Other study ID #: NIS165-003
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 19, 2021

Study information

• Verified date: June 2022
• Source: Natural Immune Systems Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 19, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hydration

Intervention

Dietary Supplement:
• Alkaline water
1.5 liters per day
• Reverse osmosis water
1.5 liters per day

Locations

Country	Name	City	State
United States	NIS Labs	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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