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

NCT04460846 | Completed

• 1 other identifier: NIS165-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Alkaline water

ACTIVE COMPARATOR

Participants will consume 1.5 liters per day

Dietary Supplement: Alkaline water

Reverse osmosis water

PLACEBO COMPARATOR

Participants will consume 1.5 liters per day

Dietary Supplement: Reverse osmosis water

Interventions

Alkaline water DIETARY_SUPPLEMENT

1.5 liters per day

Alkaline water

Reverse osmosis water DIETARY_SUPPLEMENT

1.5 liters per day

Reverse osmosis water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601-5904, United States

Location

Study Officials

• Gitte Jensen, PhD

  NIS Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled, cross-over trial

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: July 8, 2020
• Study Start: March 1, 2020
• Primary Completion: November 25, 2021
• Study Completion: December 19, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-06

Locations

US (1)