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

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

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.

Study Overview

• Status: Completed
• Conditions: Hydration
• Intervention / Treatment: Dietary supplement: Alkaline water; Dietary supplement: Reverse osmosis water

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601-5904
      • NIS Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alkaline water; Participants will consume 1.5 liters per day	Dietary supplement: Alkaline water; 1.5 liters per day
Placebo Comparator: Reverse osmosis water; Participants will consume 1.5 liters per day	Dietary supplement: Reverse osmosis water; 1.5 liters per day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc
• Investigators: Principal Investigator: Gitte Jensen, PhD, NIS Labs

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): December 19, 2021

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NIS165-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No