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

Not Applicable

Completed

• Conditions: Hydration
• Interventions: Dietary Supplement: Alkaline water; Dietary Supplement: Reverse osmosis water

• Registration Number: NCT04460846
• Lead Sponsor: Natural Immune Systems Inc

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-08
• Primary Completion: 2021-11-25
• Study Completion: 2021-12-19
• Status Verified: 2022-06
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alkaline water	Alkaline water	Participants will consume 1.5 liters per day
Reverse osmosis water	Reverse osmosis water	Participants will consume 1.5 liters per day

Primary Outcome Measures

Name	Time	Method
Evaluation of hydration status using Bioelectrical Impedance Analysis	Change from baseline to 2 weeks	Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water.

Trial Locations

Locations (1)

NIS Labs; 🇺🇸 Klamath Falls, Oregon, United States