Metabolic SyndromeHYDRO-RESPONDNCT06968715
Hydrogen-Rich Water and Metabolic Health in Adults: A 12-Week Randomized Trial
A study testing Experimental 1: low-breath hydrogen, Experimental 2: high-breath hydrogen and Experimental 3: low-breath hydrogen in people with Metabolic Syndrome, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
The HYDRO-RESPOND trial is a 12-week randomized controlled study investigating the effects of daily hydrogen-rich water (HRW) consumption on body composition and metabolic biomarkers in adults diagnosed with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Experimental 1: low-breath hydrogen, Experimental 2: high-breath hydrogen and Experimental 3: low-breath hydrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Apr 2025to 30 Nov 2025
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-65 years
- Metabolic syndrome (NHS) (at least 3 of the 5 following criteria):
- Waist circumference of ≥ 102 cm in men and ≥ 88 cm in women
- Hypertriglyceridemia (≥ 1.695 mmol/L)
- Low HDL-C (< 1.04 mmol/dL in men and < 1.30 mmol/dL in women)
- High blood pressure (> 130/85 mmHg)
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- High fasting glucose (> 6.1 mmol/L)
- Not physically active
- Informed consent signed
Who cannot join
- Major chronic disease and acute injuries
- History of dietary supplement use during the past 4 weeks
- History of metabolism-modulating pharmaceuticals use during the past 4 weeks
- No consent to randomization
- Participation in other studies
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000
About this study
Official title: The Effects of 12-week Hydrogen-rich Water Consumption on Body Composition and Metabolic Biomarkers in Adults With Metabolic Syndrome and Varying Breath Hydrogen Levels
The HYDRO-RESPOND trial is a 12-week randomized controlled study investigating the effects of daily hydrogen-rich water (HRW) consumption on body composition and metabolic biomarkers in adults diagnosed with metabolic syndrome. The study also explores whether individual differences in baseline breath hydrogen levels influence response to HRW. Participants are randomly assigned to receive either HRW or a placebo, with outcomes including changes in body fat, waist circumference, glucose metabolism, lipid profiles, and inflammatory markers. The trial aims to determine the therapeutic potential of HRW and identify predictors of individual responsiveness.
- Conditions
- Metabolic Syndrome
- Being tested
- Experimental 1: low-breath hydrogen, Experimental 2: high-breath hydrogen, Experimental 3: low-breath hydrogen, Experimental 4: high-breath hydrogen
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 1: low-breath hydrogenDietary supplement
Hydrogen-rich water (1.0 L/day)
Experimental 2: high-breath hydrogenDietary supplement
Hydrogen-rich water (1.0 L/day)
Experimental 3: low-breath hydrogenDietary supplement
Placebo water (1.0 L/day)
Experimental 4: high-breath hydrogenDietary supplement
Placebo water (1.0 L/day)
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1: low-breath hydrogen | Experimental | One liter of hydrogen-rich water per day Receives: Dietary Supplement: Experimental 1: low-breath hydrogen |
| Experimental 2: high-breath hydrogen | Experimental | One liter of hydrogen-rich water per day Receives: Dietary Supplement: Experimental 2: high-breath hydrogen |
| Experimental 3: low-breath hydrogen | Placebo comparator | One liter of control water per day Receives: Dietary Supplement: Experimental 3: low-breath hydrogen |
| Experimental 4: high-breath hydrogen | Placebo comparator | One liter of control water per day Receives: Dietary Supplement: Experimental 4: high-breath hydrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Waist circumference, measured at the midpoint between the lower rib and iliac crest, serves as an indicator of abdominal adiposity and a key outcome reflecting metabolic risk.
Measured: Change from baseline waist circumference at 12 weeks
Secondary outcomes (3)
Body fat
Body fat measured with bioimpedance analysis
Measured: Change from baseline body fat at 12 weeks
Lipoprotein (a)
Serum levels of lipoprotein (a)
Measured: Change from baseline lipoprotein (a) at 12 weeks
Total antioxidant capacity
Serum levels of total antioxidant capacity
Measured: Change from baseline total antioxidant capacity at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Apr 2025
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT06968715
- Sponsor's protocol ID
- 51-02-01
- Acronym
- HYDRO-RESPOND
- Status last verified
- Dec 2025
- First submitted
- 5 May 2025
- Last updated
- 22 Dec 2025
- 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 metabolic syndrome. 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 12-week Hydrogen-rich Water Consumption on Body Composition and Metabolic Biomarkers in Adults With Metabolic Syndrome and Varying Breath Hydrogen Levels
- ClinicalTrials.gov ID
- NCT06968715
- Acronym / sponsor ID
- HYDRO-RESPOND / 51-02-01
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 13 May 2025 (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 HYDRO-RESPOND trial is a 12-week randomized controlled study investigating the effects of daily hydrogen-rich water (HRW) consumption on body composition and metabolic biomarkers in adults diagnosed with metabolic syndrome. The study also explores whether individual differences in baseline breath hydrogen levels influence response to HRW. Participants are randomly assigned to receive either HRW or a placebo, with outcomes including changes in body fat, waist circumference, glucose metabolism, lipid profiles, and inflammatory markers. The trial aims to determine the therapeutic potential of HRW and identify predictors of individual responsiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 1: low-breath hydrogen | Experimental | Dietary Supplement: Experimental 1: low-breath hydrogenOne liter of hydrogen-rich water per day |
| Experimental 2: high-breath hydrogen | Experimental | Dietary Supplement: Experimental 2: high-breath hydrogenOne liter of hydrogen-rich water per day |
| Experimental 3: low-breath hydrogen | Placebo comparator | Dietary Supplement: Experimental 3: low-breath hydrogenOne liter of control water per day |
| Experimental 4: high-breath hydrogen | Placebo comparator | Dietary Supplement: Experimental 4: high-breath hydrogenOne liter of control water per day |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 30-65 years
- Metabolic syndrome (NHS) (at least 3 of the 5 following criteria):
- Not physically active
- Informed consent signed
Key exclusion criteria (5 listed)
- Major chronic disease and acute injuries
- History of dietary supplement use during the past 4 weeks
- History of metabolism-modulating pharmaceuticals use during the past 4 weeks
- No consent to randomization
- Participation in other studies
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 |
|---|---|---|
| Experimental 1: low-breath hydrogenHydrogen-rich water (1.0 L/day) | Dietary supplement | Experimental 1: low-breath hydrogen |
| Experimental 2: high-breath hydrogenHydrogen-rich water (1.0 L/day) | Dietary supplement | Experimental 2: high-breath hydrogen |
| Experimental 3: low-breath hydrogenPlacebo water (1.0 L/day) | Dietary supplement | Experimental 3: low-breath hydrogen |
| Experimental 4: high-breath hydrogenPlacebo water (1.0 L/day) | Dietary supplement | Experimental 4: high-breath hydrogen |
Primary outcome
Waist circumference
Time frame: Change from baseline waist circumference at 12 weeks
Waist circumference, measured at the midpoint between the lower rib and iliac crest, serves as an indicator of abdominal adiposity and a key outcome reflecting metabolic risk.
3 secondary outcomes
Body fat
Time frame: Change from baseline body fat at 12 weeks
Lipoprotein (a)
Time frame: Change from baseline lipoprotein (a) at 12 weeks
Total antioxidant capacity
Time frame: Change from baseline total antioxidant capacity at 12 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 22 Dec 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in metabolic syndrome. 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.
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 Experimental 1: low-breath hydrogen, Experimental 2: high-breath hydrogen and Experimental 3: low-breath hydrogen in people with Metabolic Syndrome, 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 9 inclusion and 5 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 22 Dec 2025. 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?
Waist circumference (time frame: Change from baseline waist circumference at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.