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Hydrogen-rich Water for Molecular and Phenotypic Biomarkers of Aging (H2AGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04430803
Recruitment Status : Not yet recruiting
First Posted : June 12, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of Novi Sad, Faculty of Sport and Physical Education

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: Hydrogen-rich water Other: Control Water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : August 15, 2020
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Hydrogen-rich water

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
Dietary Supplement: Hydrogen-rich water
A tablet that produces hydrogen dissolved in a glass of water

Placebo Comparator: Control water

Tap water

  • 0 ppm of hydrogen
  • Administered one dose two times per day on an empty stomach in the morning and at the evening
Other: Control Water
A glass of tap water




Primary Outcome Measures :
  1. Change in TeloTAGGG Telomerase PCR activity in serum [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months


Secondary Outcome Measures :
  1. Change in DNA methylation [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  2. Change in blood concentration of advanced glycation end product [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  3. Change in lipid peroxidation [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  4. Change in serum FGF21 [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  5. Change in serum TET2 [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  6. Change in ADAS-Cog score (0-70 scale, higher scores indicating greater cognitive impairment) [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  7. Change in facial wrinkling (0-100 scale; higher scores mean worse outcome) [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  8. Change in maximal oxygen uptake estimated by step-in-place test [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 70 years
  • Free of acute disorders

Exclusion Criteria:

  • History of dietary supplement use during the past 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430803


Contacts
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Contact: Sergej M Ostojic, MD, PhD +38121450188 sergej.ostojic@chess.edu.rs

Locations
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Serbia
FSPE Applied Bioenergetics Lab
Novi Sad, Vojvodina, Serbia, 21000
Sponsors and Collaborators
University of Novi Sad, Faculty of Sport and Physical Education
Publications:
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Responsible Party: University of Novi Sad, Faculty of Sport and Physical Education
ClinicalTrials.gov Identifier: NCT04430803    
Other Study ID Numbers: 281048E-HRW/2020
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No