OverweightHOPENCT07410065
Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight
A study testing Hydrogen-rich water in people with Overweight, run by Center for Health Sciences, Serbia at 1 site in Serbia.
Trial summary
The Supersaturated Hydrogen-Rich Water for Outpatients with Persistent Excess Weight (HOPE) study is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of daily consumption of supersaturated hydrogen-rich water in adults with persistent excess body… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Hydrogen-rich water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Apr 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Body mass index > 25.0 kg/m2 (persisted for at least six months before screening)
- Stable on their therapy (if any) for ≥ 3 months
- Free of acute disorders and severe chronic diseases
- Informed consent signed
- Normal fasting breath hydrogen levels < 15 ppm
Who cannot join
- History of dietary supplement use 4 weeks before the study commences
- Abnormal values for lab clinical chemistry not related with stiyd outcomes (> 2 SD)
- No consent to randomization
- Unwillingness to return for follow-up analysis
- Participation in other clinical trials
- Participants starting or changing major treatments during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight (HOPE)
The Supersaturated Hydrogen-Rich Water for Outpatients with Persistent Excess Weight (HOPE) study is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of daily consumption of supersaturated hydrogen-rich water in adults with persistent excess body weight. The trial investigates whether sustained exposure to molecular hydrogen can favorably influence body composition and key metabolic outcomes compared with a placebo water lacking dissolved hydrogen. By enrolling outpatients across multiple centers and applying rigorous blinding and randomization procedures, HOPE aims to generate high-quality clinical evidence on the potential role of hydrogen-rich water as a non-pharmacological, adjunctive strategy for weight management and metabolic health.
- Conditions
- Overweight
- Being tested
- Hydrogen-rich water, Control
- Keywords
- Metabolism, Hydrogen
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen-rich waterDietary supplement
Hydrogen-rich water (1.0 L per day)
ControlDietary supplement
Hydrogen-free water (1.0 L per day)
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen-rich water | Experimental | 1.0 L of hydrogen-rich water per day Receives: Dietary Supplement: Hydrogen-rich water |
| Control | Active comparator | 1.0 L of hydrogen-free water per day Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apolipoprotein B
Serum level of apolipoprotein B
Measured: Change from baseline apolipoprotein B at 6 months
Secondary outcomes (3)
Lipoprotein (a)
Serum level of lipoprotein (a)
Measured: Change from baseline lipoprotein (a) at 6 months
GLP-1
Serum level of GLP-1
Measured: Change from baseline GLP-1 at 6 months
Short-chain fatty acids
Serum level of short-chain fatty acids
Measured: Change from baseline short-chain fatty acids at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Health Sciences, Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikola Todorovic, PhD, Principal investigator, Center for Mitochondrial Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410065
- Sponsor's protocol ID
- 13012-20-01
- Acronym
- HOPE
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 13 Feb 2026
- 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 obesity/overweight. 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
Todorovic N, Baltic S, Nedeljkovic D, Kuzmanovic J, Korovljev D, Javorac D, Bijelic K, Kladar N, Tarnava A, Ostojic SM. The Effects of 8-Week Hydrogen-Rich Water Consumption on Appetite, Body Composition, Sleep Quality, and Circulating Glucagon-like Peptide-1 in Obese Men and Women (HYDRAPPET): A Randomized Controlled Trial. Medicina (Kaunas). 2025 Jul 18;61(7):1299. doi: 10.3390/medicina61071299.
PubMed 40731927Todorovic N, Kuzmanovic J, Javorac D, Ostojic SM. Role of molecular hydrogen in obesity treatment: modulation of GLP-1, irisin, and PGC-1alpha for improved metabolism. Med Gas Res. 2025 Sep 1;15(3):442-443. doi: 10.4103/mgr.MEDGASRES-D-24-00146. Epub 2025 Feb 7. No abstract available.
PubMed 40251025Korovljev D, Todorovic N, Ranisavljev M, Andjelic B, Kladar N, Stajer V, Ostojic SM. Hydrogen-rich water upregulates fecal propionic acid levels in overweight adults. Nutrition. 2023 Dec;116:112200. doi: 10.1016/j.nut.2023.112200. Epub 2023 Sep 1. No abstract available.
PubMed 37734117Korovljev D, Ostojic J, Todorovic N, Ostojic SM. Molecular hydrogen modulates brain glutamate/GABA-glutamine cycle in overweight humans. Arch Med Sci. 2023 Jul 13;19(4):1151-1153. doi: 10.5114/aoms/162938. eCollection 2023.
PubMed 37560746Todorovic N, Fernandez-Landa J, Santibanez A, Kura B, Stajer V, Korovljev D, Ostojic SM. The Effects of Hydrogen-Rich Water on Blood Lipid Profiles in Clinical Populations: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel). 2023 Jan 18;16(2):142. doi: 10.3390/ph16020142.
PubMed 37259294
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight (HOPE)
- ClinicalTrials.gov ID
- NCT07410065
- Acronym / sponsor ID
- HOPE / 13012-20-01
- Conditions
- Overweight
- Keywords
- Metabolism, Hydrogen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Center for Health Sciences, SerbiaUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 13 Feb 2026 (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 Supersaturated Hydrogen-Rich Water for Outpatients with Persistent Excess Weight (HOPE) study is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of daily consumption of supersaturated hydrogen-rich water in adults with persistent excess body weight. The trial investigates whether sustained exposure to molecular hydrogen can favorably influence body composition and key metabolic outcomes compared with a placebo water lacking dissolved hydrogen. By enrolling outpatients across multiple centers and applying rigorous blinding and randomization procedures, HOPE aims to generate high-quality clinical evidence on the potential role of hydrogen-rich water as a non-pharmacological, adjunctive strategy for weight management and metabolic health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen-rich water | Experimental | Dietary Supplement: Hydrogen-rich water1.0 L of hydrogen-rich water per day |
| Control | Active comparator | Dietary Supplement: Control1.0 L of hydrogen-free water per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Body mass index > 25.0 kg/m2 (persisted for at least six months before screening)
- Stable on their therapy (if any) for ≥ 3 months
- Free of acute disorders and severe chronic diseases
- Informed consent signed
Key exclusion criteria (6 listed)
- History of dietary supplement use 4 weeks before the study commences
- Abnormal values for lab clinical chemistry not related with stiyd outcomes (> 2 SD)
- No consent to randomization
- Unwillingness to return for follow-up analysis
- Participation in other clinical trials
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 waterHydrogen-rich water (1.0 L per day) | Dietary supplement | Hydrogen-rich water |
| ControlHydrogen-free water (1.0 L per day) | Dietary supplement | Control |
Primary outcome
Apolipoprotein B
Time frame: Change from baseline apolipoprotein B at 6 months
Serum level of apolipoprotein B
3 secondary outcomes
Lipoprotein (a)
Time frame: Change from baseline lipoprotein (a) at 6 months
GLP-1
Time frame: Change from baseline GLP-1 at 6 months
Short-chain fatty acids
Time frame: Change from baseline short-chain fatty acids at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 40731927Todorovic N, Baltic S, Nedeljkovic D, Kuzmanovic J, Korovljev D, Javorac D, Bijelic K, Kladar N, Tarnava A, Ostojic SM. The Effects of 8-Week Hydrogen-Rich Water Consumption on Appetite, Body Composition, Sleep Quality, and Circulating Glucagon-like Peptide-1 in Obese Men and Women (HYDRAPPET): A Randomized Controlled Trial. Medicina (Kaunas). 2025 Jul 18;61(7):1299. doi: 10.3390/medicina61071299.
- Background: PubMed 40251025Todorovic N, Kuzmanovic J, Javorac D, Ostojic SM. Role of molecular hydrogen in obesity treatment: modulation of GLP-1, irisin, and PGC-1alpha for improved metabolism. Med Gas Res. 2025 Sep 1;15(3):442-443. doi: 10.4103/mgr.MEDGASRES-D-24-00146. Epub 2025 Feb 7. No abstract available.
- Background: PubMed 37734117Korovljev D, Todorovic N, Ranisavljev M, Andjelic B, Kladar N, Stajer V, Ostojic SM. Hydrogen-rich water upregulates fecal propionic acid levels in overweight adults. Nutrition. 2023 Dec;116:112200. doi: 10.1016/j.nut.2023.112200. Epub 2023 Sep 1. No abstract available.
- Background: PubMed 37560746Korovljev D, Ostojic J, Todorovic N, Ostojic SM. Molecular hydrogen modulates brain glutamate/GABA-glutamine cycle in overweight humans. Arch Med Sci. 2023 Jul 13;19(4):1151-1153. doi: 10.5114/aoms/162938. eCollection 2023.
- Background: PubMed 37259294Todorovic N, Fernandez-Landa J, Santibanez A, Kura B, Stajer V, Korovljev D, Ostojic SM. The Effects of Hydrogen-Rich Water on Blood Lipid Profiles in Clinical Populations: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel). 2023 Jan 18;16(2):142. doi: 10.3390/ph16020142.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in obesity/overweight. 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.
Nikola Todorovic, PhD principal investigator
Center for Mitochondrial Medicine
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 Overweight, run by Center for Health Sciences, Serbia 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergej Ostojic, MD, PhD (+381112643242, sergej.ostojic@chess.edu.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apolipoprotein B (time frame: Change from baseline apolipoprotein B at 6 months). 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 NCT07410065, which also lists 5 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 13 Feb 2026.