<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/NCT04430803</url>
  </required_header>
  <id_info>
    <org_study_id>281048E-HRW/2020</org_study_id>
    <nct_id>NCT04430803</nct_id>
  </id_info>
  <brief_title>Hydrogen-rich Water for Molecular and Phenotypic Biomarkers of Aging</brief_title>
  <acronym>H2AGE</acronym>
  <official_title>The Effects of Six-month Hydrogen-rich Water Intake on Molecular and Phenotypic Biomarkers of Aging in Men and Women Aged 70 Years and Over: a Randomized-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Novi Sad, Faculty of Sport and Physical Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Novi Sad, Faculty of Sport and Physical Education</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>
      This study evaluates the effects of six-month hydrogen-rich water intake on molecular and&#xD;
      phenotypic biomarkers of aging in men and women aged 70 years and over.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in TeloTAGGG Telomerase PCR activity in serum</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in DNA methylation</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood concentration of advanced glycation end product</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid peroxidation</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum FGF21</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum TET2</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ADAS-Cog score (0-70 scale, higher scores indicating greater cognitive impairment)</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in facial wrinkling (0-100 scale; higher scores mean worse outcome)</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maximal oxygen uptake estimated by step-in-place test</measure>
    <time_frame>Baseline vs. 6 months post-intervention</time_frame>
    <description>Baseline vs. 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Hydrogen-rich water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrogen-rich water (Rejuvenation, HRW Natural Health Products Inc.)&#xD;
8 ppm of hydrogen&#xD;
Administered one dose two times per day on an empty stomach in the morning and at the evening</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tap water&#xD;
0 ppm of hydrogen&#xD;
Administered one dose two times per day on an empty stomach in the morning and at the evening</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hydrogen-rich water</intervention_name>
    <description>A tablet that produces hydrogen dissolved in a glass of water</description>
    <arm_group_label>Hydrogen-rich water</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Water</intervention_name>
    <description>A glass of tap water</description>
    <arm_group_label>Control water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 70 years&#xD;
&#xD;
          -  Free of acute disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of dietary supplement use during the past 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>FSPE Applied Bioenergetics Lab</name>
      <address>
        <city>Novi Sad</city>
        <state>Vojvodina</state>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <reference>
    <citation>Xia X, Chen W, McDermott J, Han JJ. Molecular and phenotypic biomarkers of aging. F1000Res. 2017 Jun 9;6:860. doi: 10.12688/f1000research.10692.1. eCollection 2017.</citation>
    <PMID>28663789</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04430803
org study id: 281048E-HRW/2020
nct id: NCT04430803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effects of six-month hydrogen-rich water intake on molecular and
      phenotypic biomarkers of aging in men and women aged 70 years and over.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in TeloTAGGG Telomerase PCR activity in serum
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
measure: Change in DNA methylation
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
measure: Change in blood concentration of advanced glycation end product
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
measure: Change in lipid peroxidation
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
measure: Change in serum FGF21
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
measure: Change in serum TET2
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
measure: Change in ADAS-Cog score (0-70 scale, higher scores indicating greater cognitive impairment)
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
measure: Change in facial wrinkling (0-100 scale; higher scores mean worse outcome)
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
measure: Change in maximal oxygen uptake estimated by step-in-place test
time frame: Baseline vs. 6 months post-intervention
description: Baseline vs. 6 months
arm group label: Hydrogen-rich water
arm group type: Experimental
description: Hydrogen-rich water (Rejuvenation, HRW Natural Health Products Inc.)
8 ppm of hydrogen
Administered one dose two times per day on an empty stomach in the morning and at the evening
arm group label: Control water
arm group type: Placebo Comparator
description: Tap water
0 ppm of hydrogen
Administered one dose two times per day on an empty stomach in the morning and at the evening
intervention type: Dietary Supplement
intervention name: Hydrogen-rich water
description: A tablet that produces hydrogen dissolved in a glass of water
arm group label: Hydrogen-rich water
intervention type: Other
intervention name: Control Water
description: A glass of tap water
arm group label: Control water
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Serbia
citation: Xia X, Chen W, McDermott J, Han JJ. Molecular and phenotypic biomarkers of aging. F1000Res. 2017 Jun 9;6:860. doi: 10.12688/f1000research.10692.1. eCollection 2017.
PMID: 28663789
responsible party type: Sponsor
sharing ipd: No