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

NCT ID: NCT04460846

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-12-19

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.

Conditions

Hydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Alkaline water

Participants will consume 1.5 liters per day

Group Type: ACTIVE_COMPARATOR

Alkaline water

Intervention Type: DIETARY_SUPPLEMENT

1.5 liters per day

Reverse osmosis water

Participants will consume 1.5 liters per day

Group Type: PLACEBO_COMPARATOR

Reverse osmosis water

Intervention Type: DIETARY_SUPPLEMENT

1.5 liters per day

Interventions

Alkaline water

1.5 liters per day

Intervention Type: DIETARY_SUPPLEMENT

Reverse osmosis water

1.5 liters per day

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Natural Immune Systems Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gitte Jensen, PhD

Role: PRINCIPAL_INVESTIGATOR

NIS Labs

Locations

NIS Labs

Klamath Falls, Oregon, United States

Countries

United States

Other Identifiers

NIS165-003

Identifier Type: -

Identifier Source: org_study_id