ObesityHYDRAPPETNCT06722326
Hydrogen-rich Water and Appetite in Obesity
A study testing Dietary Supplement: Hydrogen-rich water in people with Obesity, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
The main goal of this study is to investigate how dihydrogen supplementation impacts body composition, appetite, quality of life specific to obesity, and levels of the hormone GLP-1 in men and women with obesity. This randomized controlled trial aims to explore whether dihydrogen can improve these health indicators. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary Supplement: Hydrogen-rich water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSerbia
- Study dates
- 15 May 2024to 30 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Body fat > 30% in women and > 25% in men
- 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 obesity pharmaceuticals use during the past 8 weeks
- No consent to randomization
- Participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of 8-week Hydrogen-rich Water Consumption on Body Composition, Appetite and Obesity-specific Quality of Life, and Circulating Glucagon-like Peptide-1 in Obese Men and Women (Hydrappet): a Randomized Controlled Trial
The main goal of this study is to investigate how dihydrogen supplementation impacts body composition, appetite, quality of life specific to obesity, and levels of the hormone GLP-1 in men and women with obesity. This randomized controlled trial aims to explore whether dihydrogen can improve these health indicators.
Read the detailed description
The primary aim of this randomized controlled trial is to evaluate the effects of dihydrogen supplementation on body composition indices, appetite, obesity-specific quality of life, and circulating GLP-1 levels in obese men and women
- Conditions
- Obesity
- Being tested
- Dietary Supplement: Hydrogen-rich water, Dietary Supplement: Control water
- Keywords
- dihydrogen, appetite, LDL cholesterol, supplementation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Hydrogen-rich waterDietary supplement
Hydrogen-rich water with 12 mg of hydrogen per serving
Dietary Supplement: Control waterDietary supplement
Control water with 0 mg of hydrogen per serving
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen-rich water | Experimental | One liter per day of hydrogen rich water Receives: Dietary Supplement: Dietary Supplement: Hydrogen-rich water |
| Control water | Placebo comparator | One liter per day of tap water Receives: Dietary Supplement: Dietary Supplement: Control water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite
Total scores for appetite as assessed by the the Food Cravings Questionnaire (FCQ)
Measured: Change from baseline appetite at 8 weeks
Secondary outcomes (3)
Obesity-related quality or life
Total scores for obesity-related quality of life as assessed by the The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire
Measured: Change from baseline total scores for obesity-related quality of life at 8 weeks
Body fat
Percentage of body fat as assessed by a multifrequency bioelectrical impedance analyzer
Measured: Change from baseline body fat at 8 weeks
Serum GLP-1
Serum levels of glucagon-like peptide-1 (GLP-1)
Measured: Change from baseline GLP-1 at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 May 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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 ObesityStudies 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, Care provider
- Enrolment
- 36 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722326
- Sponsor's protocol ID
- 03-HRW-24
- Acronym
- HYDRAPPET
- Status last verified
- Jan 2025
- First submitted
- 3 Dec 2024
- Last updated
- 20 Jan 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 obesity. 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
Korovljev 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, 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 40731927
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 8-week Hydrogen-rich Water Consumption on Body Composition, Appetite and Obesity-specific Quality of Life, and Circulating Glucagon-like Peptide-1 in Obese Men and Women (Hydrappet): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06722326
- Acronym / sponsor ID
- HYDRAPPET / 03-HRW-24
- Conditions
- Obesity
- Keywords
- dihydrogen, appetite, LDL cholesterol, supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 9 Dec 2024 (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 main goal of this study is to investigate how dihydrogen supplementation impacts body composition, appetite, quality of life specific to obesity, and levels of the hormone GLP-1 in men and women with obesity. This randomized controlled trial aims to explore whether dihydrogen can improve these health indicators.
Detailed description
The primary aim of this randomized controlled trial is to evaluate the effects of dihydrogen supplementation on body composition indices, appetite, obesity-specific quality of life, and circulating GLP-1 levels in obese men and women
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen-rich water | Experimental | Dietary Supplement: Dietary Supplement: Hydrogen-rich waterOne liter per day of hydrogen rich water |
| Control water | Placebo comparator | Dietary Supplement: Dietary Supplement: Control waterOne liter per day of tap water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Body fat > 30% in women and > 25% in men
- 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 obesity pharmaceuticals use during the past 8 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 |
|---|---|---|
| Dietary Supplement: Hydrogen-rich waterHydrogen-rich water with 12 mg of hydrogen per serving | Dietary supplement | Hydrogen-rich water |
| Dietary Supplement: Control waterControl water with 0 mg of hydrogen per serving | Dietary supplement | Control water |
Primary outcome
Appetite
Time frame: Change from baseline appetite at 8 weeks
Total scores for appetite as assessed by the the Food Cravings Questionnaire (FCQ)
3 secondary outcomes
Obesity-related quality or life
Time frame: Change from baseline total scores for obesity-related quality of life at 8 weeks
Body fat
Time frame: Change from baseline body fat at 8 weeks
Serum GLP-1
Time frame: Change from baseline GLP-1 at 8 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 20 Jan 2025.
- 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.
- Derived from this study: 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.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in obesity. 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 Dietary Supplement: Hydrogen-rich water in people with Obesity, 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 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 20 Jan 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?
Appetite (time frame: Change from baseline appetite at 8 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 NCT06722326, 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 20 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.