AgingHYDRORESNCT06163287
Hydrogen-Rich Water and Exercise-Related Biomarkers in Men and Women Over 50 Years
A study testing Supplement in people with Aging, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
The study investigates the impact of consuming hydrogen-rich water over a six-week period on exercise-related biomarkers among individuals aged over 50, both men and women, who undergo a resistance training program. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Oct 2023to 31 Mar 2024
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 - 65 years (at least 50% would be over 60 years)
- Body mass index 18.5 - 29.9 kg/m2
- Free of major chronic diseases or acute disorders
- Resistance exercise naïve (no resistance traiing during 6 months before study commences)
Who cannot join
- History of dietary supplement use during the 4 weeks before study commences
- Unwillingness to return for follow-up analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Drinking Hydrogen-rich Water for 6 Weeks on Exercise-related Biomarkers in Men and Women Over 50 Years Following Resistance Training Program: a Randomized Controlled Pilot Trial
The study investigates the impact of consuming hydrogen-rich water over a six-week period on exercise-related biomarkers among individuals aged over 50, both men and women, who undergo a resistance training program. This research aims to discern the potential benefits of hydrogen-infused water consumption concerning exercise-related markers in an aging demographic post-resistance training.
- Conditions
- Aging
- Being tested
- Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
Dietary supplement containing molecular hydrogen
PlaceboDietary supplement
Inert substance
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | One tablet of hydrogen-rich supplement before breakfast and dinner Receives: Dietary Supplement: Supplement |
| Placebo | Placebo comparator | One tablet of hydrogen-free supplement before breakfast and dinner Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
36-Item Short Form Health Survey
Short Form Health Survey total score, minimum and maximum possible score of between 0 and 100, with higher scores mean better outcome
Measured: Change from baseline 36-Item Short Form Health Survey total score at 6 weeks
Secondary outcomes (4)
Grip strength
Muscular strength generated by one's forearm muscles
Measured: Change from baseline grip strength at 6 weeks
Myoglobin
Level of myoglobin in serum
Measured: Change from baseline serum myoglobine at 6 weeks
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index score, a score ranging from 0 to 3, with 3 indicating the greatest dysfunction
Measured: Change from baseline Pittsburgh Sleep Quality Index score at 6 weeks
Dehydroepiandrosterone
Level of dehydroepiandrosterone in serum
Measured: Change from baseline serum dehydroepiandrosterone at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Oct 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- Principal investigator, Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
- Investigators
- Sergej Ostojic, MD, PhD, Principal investigator, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163287
- Sponsor's protocol ID
- HRW-1-23-AL
- Acronym
- HYDRORES
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in hydrogen research in biomedicine. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Publications
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.
PubMed 34601077Korovljev D, Trivic T, Drid P, Ostojic SM. Molecular hydrogen affects body composition, metabolic profiles, and mitochondrial function in middle-aged overweight women. Ir J Med Sci. 2018 Feb;187(1):85-89. doi: 10.1007/s11845-017-1638-4. Epub 2017 May 30.
PubMed 28560519Korovljev D, Stajer V, Javorac D, Ostojic SM. Hydrogen inhalation positively affects cardiometabolic risk factors in men and women aged 65 years or older: a preliminary report. Eur Geriatr Med. 2018 Oct;9(5):729-730. doi: 10.1007/s41999-018-0087-6. Epub 2018 Jul 31. No abstract available.
PubMed 34654221
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Drinking Hydrogen-rich Water for 6 Weeks on Exercise-related Biomarkers in Men and Women Over 50 Years Following Resistance Training Program: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06163287
- Acronym / sponsor ID
- HYDRORES / HRW-1-23-AL
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 8 Dec 2023 (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.
The study investigates the impact of consuming hydrogen-rich water over a six-week period on exercise-related biomarkers among individuals aged over 50, both men and women, who undergo a resistance training program. This research aims to discern the potential benefits of hydrogen-infused water consumption concerning exercise-related markers in an aging demographic post-resistance training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: SupplementOne tablet of hydrogen-rich supplement before breakfast and dinner |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne tablet of hydrogen-free supplement before breakfast and dinner |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50 - 65 years (at least 50% would be over 60 years)
- Body mass index 18.5 - 29.9 kg/m2
- Free of major chronic diseases or acute disorders
- Resistance exercise naïve (no resistance traiing during 6 months before study commences)
Key exclusion criteria (2 listed)
- History of dietary supplement use during the 4 weeks before study commences
- Unwillingness to return for follow-up analysis
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 |
|---|---|---|
| SupplementDietary supplement containing molecular hydrogen | Dietary supplement | Supplement |
| PlaceboInert substance | Dietary supplement | Placebo |
Primary outcome
36-Item Short Form Health Survey
Time frame: Change from baseline 36-Item Short Form Health Survey total score at 6 weeks
Short Form Health Survey total score, minimum and maximum possible score of between 0 and 100, with higher scores mean better outcome
4 secondary outcomes
Grip strength
Time frame: Change from baseline grip strength at 6 weeks
Myoglobin
Time frame: Change from baseline serum myoglobine at 6 weeks
Pittsburgh Sleep Quality Index
Time frame: Change from baseline Pittsburgh Sleep Quality Index score at 6 weeks
Dehydroepiandrosterone
Time frame: Change from baseline serum dehydroepiandrosterone at 6 weeks
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 4 Dec 2024.
- Background: 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.
- Background: PubMed 28560519Korovljev D, Trivic T, Drid P, Ostojic SM. Molecular hydrogen affects body composition, metabolic profiles, and mitochondrial function in middle-aged overweight women. Ir J Med Sci. 2018 Feb;187(1):85-89. doi: 10.1007/s11845-017-1638-4. Epub 2017 May 30.
- Background: PubMed 34654221Korovljev D, Stajer V, Javorac D, Ostojic SM. Hydrogen inhalation positively affects cardiometabolic risk factors in men and women aged 65 years or older: a preliminary report. Eur Geriatr Med. 2018 Oct;9(5):729-730. doi: 10.1007/s41999-018-0087-6. Epub 2018 Jul 31. No abstract available.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in hydrogen research in biomedicine. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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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.
Sergej Ostojic, MD, PhD principal investigator
University of Novi Sad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement 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 4 inclusion and 2 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 4 Dec 2024. 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?
36-Item Short Form Health Survey (time frame: Change from baseline 36-Item Short Form Health Survey total score at 6 weeks). 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 NCT06163287, which also lists 3 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 4 Dec 2024.