<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04460846</url>
  </required_header>
  <id_info>
    <org_study_id>NIS165-003</org_study_id>
    <nct_id>NCT04460846</nct_id>
  </id_info>
  <brief_title>Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water.</brief_title>
  <official_title>Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water: A Randomized Controlled Cross-over Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Natural Immune Systems Inc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Natural Immune Systems Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population&#xD;
      of chronically, moderately dehydrated people comparing two waters on hydration status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double-blinded, placebo-controlled cross-over study design will be used to&#xD;
      evaluate the effects of consumption of alkaline water against reverse osmosis water. The&#xD;
      study is of 5 weeks' duration, with evaluation at baseline, 2 weeks (beginning of wash-out&#xD;
      period), 3 weeks (end of wash-out period), and 5 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">December 19, 2021</completion_date>
  <primary_completion_date type="Actual">November 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized, double-blinded, placebo-controlled, cross-over trial</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of hydration status using Bioelectrical Impedance Analysis</measure>
    <time_frame>Change from baseline to 2 weeks</time_frame>
    <description>Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Hydration</condition>
  <arm_group>
    <arm_group_label>Alkaline water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will consume 1.5 liters per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reverse osmosis water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will consume 1.5 liters per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Alkaline water</intervention_name>
    <description>1.5 liters per day</description>
    <arm_group_label>Alkaline water</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Reverse osmosis water</intervention_name>
    <description>1.5 liters per day</description>
    <arm_group_label>Reverse osmosis water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult people of either gender;&#xD;
&#xD;
          -  Age 18 - 65 years (inclusive);&#xD;
&#xD;
          -  BMI between 18.0 and 34.9 (inclusive);&#xD;
&#xD;
          -  Screening results showing at least one of the following:&#xD;
&#xD;
               -  Hematocrit: Women: 45.0 or higher; Men: 48.7 or higher;&#xD;
&#xD;
               -  BUN/Creatinine ratio 20 or higher;&#xD;
&#xD;
               -  Sodium levels 146 mmol/L or higher;&#xD;
&#xD;
               -  Potassium levels 5.3 mmol/L or higher;&#xD;
&#xD;
               -  Chloride levels 108 mmol/L or higher.&#xD;
&#xD;
          -  Willing to maintain a consistent diet (including medications, vitamins and&#xD;
             supplements) and lifestyle routine throughout the study;&#xD;
&#xD;
          -  Willing to abstain from coffee, tea, soft drinks, and nicotine for at least one hour&#xD;
             prior to a clinic visit;&#xD;
&#xD;
          -  Willing to abstain from alcohol for at least 12 hours prior to a clinic visit;&#xD;
&#xD;
          -  Willing to maintain a consistent habit of abstaining from exercising and nutritional&#xD;
             supplements on the morning of a study visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer during past 12 months;&#xD;
&#xD;
          -  Chemotherapy during past 12 months;&#xD;
&#xD;
          -  Significant active uncontrolled illness (such as lymphoma, liver disease, kidney&#xD;
             failure, heart failure).&#xD;
&#xD;
          -  Previous major surgery to stomach or intestines [(absorption of test product may be&#xD;
             altered) minor surgery is not a problem, including appendix and gallbladder removal];&#xD;
&#xD;
          -  Implanted electronic device such as pacemaker or implantable&#xD;
             cardioverter-defibrillator (ICD);&#xD;
&#xD;
          -  Currently experiencing peripheral edema in legs and /or feet;&#xD;
&#xD;
          -  Diagnosed with any blood clotting disorder or taking clotting factor concentrates;&#xD;
&#xD;
          -  Diagnosis of Peripheral Artery Disease;&#xD;
&#xD;
          -  Diagnosis of varicose veins;&#xD;
&#xD;
          -  Currently taking blood pressure medication;&#xD;
&#xD;
          -  Currently taking blood thinning medication (81mg aspirin allowed);&#xD;
&#xD;
          -  Currently taking diuretic medication;&#xD;
&#xD;
          -  Currently taking nutritional supplements and other substances judged by the study&#xD;
             coordinator to negate or camouflage the effects of the test product;&#xD;
&#xD;
          -  Women who are pregnant, nursing, or trying to become pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gitte Jensen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIS Labs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NIS Labs</name>
      <address>
        <city>Klamath Falls</city>
        <state>Oregon</state>
        <zip>97601-5904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>March 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04460846
org study id: NIS165-003
nct id: NCT04460846
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, double-blinded, placebo-controlled, cross-over trial
primary purpose: Basic Science
masking: Single (Investigator)
measure: Evaluation of hydration status using Bioelectrical Impedance Analysis
time frame: Change from baseline to 2 weeks
description: Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water.
arm group label: Alkaline water
arm group type: Active Comparator
description: Participants will consume 1.5 liters per day
arm group label: Reverse osmosis water
arm group type: Placebo Comparator
description: Participants will consume 1.5 liters per day
intervention type: Dietary Supplement
intervention name: Alkaline water
description: 1.5 liters per day
arm group label: Alkaline water
intervention type: Dietary Supplement
intervention name: Reverse osmosis water
description: 1.5 liters per day
arm group label: Reverse osmosis water
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gitte Jensen, PhD
role: Principal Investigator
affiliation: NIS Labs
facility: 
country: United States
responsible party type: Sponsor