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

April 26, 2021 updated by: University of Novi Sad, Faculty of Sport and Physical Education

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • FSPE Applied Bioenergetics Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

68 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 70 years
  • Free of acute disorders

Exclusion Criteria:

  • History of dietary supplement use during the past 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in TeloTAGGG Telomerase PCR activity in serum
Time Frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
Baseline vs. 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DNA methylation
Time Frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
Baseline vs. 6 months post-intervention
Change in blood concentration of advanced glycation end product
Time Frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
Baseline vs. 6 months post-intervention
Change in lipid peroxidation
Time Frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
Baseline vs. 6 months post-intervention
Change in serum FGF21
Time Frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
Baseline vs. 6 months post-intervention
Change in serum TET2
Time Frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
Baseline vs. 6 months post-intervention
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
Baseline vs. 6 months post-intervention
Change in facial wrinkling (0-100 scale; higher scores mean worse outcome)
Time Frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
Baseline vs. 6 months post-intervention
Change in maximal oxygen uptake estimated by step-in-place test
Time Frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
Baseline vs. 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

June 7, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 281048E-HRW/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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