NCT04430803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

June 7, 2020

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in TeloTAGGG Telomerase PCR activity in serum

    Baseline vs. 6 months

    Baseline vs. 6 months post-intervention

Secondary Outcomes (8)

  • Change in DNA methylation

    Baseline vs. 6 months post-intervention

  • Change in blood concentration of advanced glycation end product

    Baseline vs. 6 months post-intervention

  • Change in lipid peroxidation

    Baseline vs. 6 months post-intervention

  • Change in serum FGF21

    Baseline vs. 6 months post-intervention

  • Change in serum TET2

    Baseline vs. 6 months post-intervention

  • +3 more secondary outcomes

Study Arms (2)

Hydrogen-rich water

EXPERIMENTAL

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

Control water

PLACEBO COMPARATOR

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

Interventions

Hydrogen-rich waterDIETARY_SUPPLEMENT

A tablet that produces hydrogen dissolved in a glass of water

Hydrogen-rich water

A glass of tap water

Control water

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \> 70 years
  • Free of acute disorders

You may not qualify if:

  • History of dietary supplement use during the past 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (2)

  • 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: 28663789BACKGROUND
  • Zanini D, Todorovic N, Korovljev D, Stajer V, Ostojic J, Purac J, Kojic D, Vukasinovic E, Djordjievski S, Sopic M, Guzonjic A, Ninic A, Erceg S, Ostojic SM. The effects of 6-month hydrogen-rich water intake on molecular and phenotypic biomarkers of aging in older adults aged 70 years and over: A randomized controlled pilot trial. Exp Gerontol. 2021 Nov;155:111574. doi: 10.1016/j.exger.2021.111574. Epub 2021 Oct 1.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 12, 2020

Study Start

September 15, 2020

Primary Completion

March 15, 2021

Study Completion

April 1, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations