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Completed

NCT Number: NCT04460846

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIS Labs

Klamath Falls, Oregon, 97601-5904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alkaline water

Dietary Supplement

1.5 liters per day

Reverse osmosis water

Dietary Supplement

1.5 liters per day

Primary outcomes

  1. Evaluation of hydration status using Bioelectrical Impedance Analysis

    Time frame: Change from baseline to 2 weeks

    Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water.

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2020
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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