AgingH2AGENCT04430803
Hydrogen-rich Water for Molecular and Phenotypic Biomarkers of Aging
A study testing Hydrogen-rich water in people with Aging, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Hydrogen-rich water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Sep 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age > 70 years
- Free of acute disorders
Who cannot join
- History of dietary supplement use during the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Aging
- Being tested
- Hydrogen-rich water, Control Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen-rich waterDietary supplement
A tablet that produces hydrogen dissolved in a glass of water
Control WaterOther
A glass of tap water
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Control Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TeloTAGGG Telomerase PCR activity in serum
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Secondary outcomes (8)
Change in DNA methylation
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in blood concentration of advanced glycation end product
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in lipid peroxidation
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in serum FGF21
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in serum TET2
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in ADAS-Cog score (0-70 scale, higher scores indicating greater cognitive impairment)
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in facial wrinkling (0-100 scale; higher scores mean worse outcome)
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in maximal oxygen uptake estimated by step-in-place test
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start15 Sep 2020
- Primary completion15 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430803
- Sponsor's protocol ID
- 281048E-HRW/2020
- Acronym
- H2AGE
- Status last verified
- Apr 2021
- First submitted
- 7 Jun 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28663789Zanini 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.
PubMed 34601077
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04430803
- Acronym / sponsor ID
- H2AGE / 281048E-HRW/2020
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen-rich water | Experimental | Dietary Supplement: Hydrogen-rich waterHydrogen-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 |
| Control water | Placebo comparator | Other: Control WaterTap water * 0 ppm of hydrogen * Administered one dose two times per day on an empty stomach in the morning and at the evening |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age > 70 years
- Free of acute disorders
Key exclusion criteria (1 listed)
- History of dietary supplement use during the past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen-rich waterA tablet that produces hydrogen dissolved in a glass of water | Dietary supplement | Hydrogen-rich water |
| Control WaterA glass of tap water | Other | Control water |
Primary outcome
Change in TeloTAGGG Telomerase PCR activity in serum
Time frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
8 secondary outcomes
Change in DNA methylation
Time frame: Baseline vs. 6 months post-intervention
Change in blood concentration of advanced glycation end product
Time frame: Baseline vs. 6 months post-intervention
Change in lipid peroxidation
Time frame: Baseline vs. 6 months post-intervention
Change in serum FGF21
Time frame: Baseline vs. 6 months post-intervention
Change in serum TET2
Time frame: 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
Change in facial wrinkling (0-100 scale; higher scores mean worse outcome)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 28663789Xia 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.
- Derived from this study: PubMed 34601077Zanini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen-rich water in people with Aging, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TeloTAGGG Telomerase PCR activity in serum (time frame: Baseline vs. 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430803, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.