Non-Alcoholic Fatty Liver DiseaseNCT03625362
Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease
A study testing Hydrogen in people with Non-Alcoholic Fatty Liver Disease, run by University of Novi Sad, Faculty of Sport and Physical Education at 2 sites in Serbia.
Trial summary
This study evaluates how 4-week supplementation with hydrogen-rich water affects liver fat accumulation, blood lipid profiles and body composition in patients with non-alcoholic fatty liver disease Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Hydrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesSerbia
- Study dates
- 1 Sep 2018to 31 Dec 2018
- 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 years
- Body mass index > 25 kg/m2
- Free of major diseases besides NAFLD
- Must be able to give written informed consent
Who cannot join
- Use of any dietary supplements within 4 weeks before study commences
- Abnormal values for lab clinical chemistry (> 2 SD)
Trial locations and contacts
2 sites in 1 country.
Serbia2 sites
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000
FSPE Applied Bioenergetics Lab
Novi Sad, Vojvodina, 21000
About this study
Official title: Effects of Hydrogen-rich Water on Liver Fat Accumulation, Blood Lipids and Body Fatness in Patients With Non-alchoholic Fatty Liver Disease
This study evaluates how 4-week supplementation with hydrogen-rich water affects liver fat accumulation, blood lipid profiles and body composition in patients with non-alcoholic fatty liver disease
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder characterized by liver fat deposition due to causes other than excessive alcohol consumption. NAFLD can cause many liver dysfunction-related symptoms and signs, with the disease may progress to non-alcoholic steatohepatitis, a condition marked by liver inflammation, fibrosis and irreversible damage. NAFLD is usually accompanied by insulin resistance and obesity, with up to 30% of population in industrialized countries have NAFLD. While NAFLD is rapidly becoming the most common liver disease worldwide, its treatment remains elusive, and directed toward correction of the risk factors. Since metabolic impairment plays a major role in NAFLD pathogenesis, any agent that advance lipid and glucose metabolism could be appropriate to tackle this complex condition. Molecular hydrogen (H2) has recently emerged as a novel pro-metabolic agent that might positively affect liver health. Supplemental hydrogen improves blood lipid profiles and insulin resistance in overweight women, patients with type 2 diabetes, and in subjects with potential metabolic syndrome. In addition, drinking hydrogen-rich water reduces hepatic oxidative stress and alleviated fatty liver damage in rodents. However, no human studies so far evaluated its effectiveness to alter liver steatosis in patients with NAFLD. In this pilot trial, we analyze the effects of 4-week hydrogen-rich water intake on liver fat deposition, body composition and lab chemistry profiles in overweight patients suffering from NAFLD.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Hydrogen, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrogenDietary supplement
Hydrogen-rich water
PlaceboDietary supplement
Tap water
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen | Experimental | 1 L of hydrogen-rich water Receives: Dietary Supplement: Hydrogen |
| Placebo | Placebo comparator | 1 L of tap water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
MRS spectra for liver triglycerides
Measured: Change from baseline liver triglycerides at 4 weeks
Secondary outcomes (2)
Total cholesterol
Level of total cholesterol in the blood
Measured: Change from baseline total cholesterol at 4 weeks
Total body fatness
Fat percentage evaluated by BIA
Measured: Change from baseline fat percentage at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 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
- NCT03625362
- Sponsor's protocol ID
- 0417-HRW/2018
- Status last verified
- Apr 2019
- First submitted
- 6 Aug 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared via Institutional repository
Publications
Kajiyama S, Hasegawa G, Asano M, Hosoda H, Fukui M, Nakamura N, Kitawaki J, Imai S, Nakano K, Ohta M, Adachi T, Obayashi H, Yoshikawa T. Supplementation of hydrogen-rich water improves lipid and glucose metabolism in patients with type 2 diabetes or impaired glucose tolerance. Nutr Res. 2008 Mar;28(3):137-43. doi: 10.1016/j.nutres.2008.01.008.
PubMed 19083400Nakao A, Toyoda Y, Sharma P, Evans M, Guthrie N. Effectiveness of hydrogen rich water on antioxidant status of subjects with potential metabolic syndrome-an open label pilot study. J Clin Biochem Nutr. 2010 Mar;46(2):140-9. doi: 10.3164/jcbn.09-100. Epub 2010 Feb 24.
PubMed 20216947Korovljev 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, Ostojic J, LeBaron TW, Ostojic SM. Hydrogen-rich water reduces liver fat accumulation and improves liver enzyme profiles in patients with non-alcoholic fatty liver disease: a randomized controlled pilot trial. Clin Res Hepatol Gastroenterol. 2019 Nov;43(6):688-693. doi: 10.1016/j.clinre.2019.03.008. Epub 2019 Apr 11.
PubMed 30982748
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrogen-rich Water on Liver Fat Accumulation, Blood Lipids and Body Fatness in Patients With Non-alchoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03625362
- Acronym / sponsor ID
- 0417-HRW/2018
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Aug 2018 (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 how 4-week supplementation with hydrogen-rich water affects liver fat accumulation, blood lipid profiles and body composition in patients with non-alcoholic fatty liver disease
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder characterized by liver fat deposition due to causes other than excessive alcohol consumption. NAFLD can cause many liver dysfunction-related symptoms and signs, with the disease may progress to non-alcoholic steatohepatitis, a condition marked by liver inflammation, fibrosis and irreversible damage. NAFLD is usually accompanied by insulin resistance and obesity, with up to 30% of population in industrialized countries have NAFLD. While NAFLD is rapidly becoming the most common liver disease worldwide, its treatment remains elusive, and directed toward correction of the risk factors. Since metabolic impairment plays a major role in NAFLD pathogenesis, any agent that advance lipid and glucose metabolism could be appropriate to tackle this complex condition. Molecular hydrogen (H2) has recently emerged as a novel pro-metabolic agent that might positively affect liver health. Supplemental hydrogen improves blood lipid profiles and insulin resistance in overweight women, patients with type 2 diabetes, and in subjects with potential metabolic syndrome. In addition, drinking hydrogen-rich water reduces hepatic oxidative stress and alleviated fatty liver damage in rodents. However, no human studies so far evaluated its effectiveness to alter liver steatosis in patients with NAFLD. In this pilot trial, we analyze the effects of 4-week hydrogen-rich water intake on liver fat deposition, body composition and lab chemistry profiles in overweight patients suffering from NAFLD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen | Experimental | Dietary Supplement: Hydrogen1 L of hydrogen-rich water |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 L 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 years
- Body mass index > 25 kg/m2
- Free of major diseases besides NAFLD
- Must be able to give written informed consent
Key exclusion criteria (2 listed)
- Use of any dietary supplements within 4 weeks before study commences
- Abnormal values for lab clinical chemistry (> 2 SD)
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 |
|---|---|---|
| HydrogenHydrogen-rich water | Dietary supplement | Hydrogen |
| PlaceboTap water | Dietary supplement | Placebo |
Primary outcome
Liver fat content
Time frame: Change from baseline liver triglycerides at 4 weeks
MRS spectra for liver triglycerides
2 secondary outcomes
Total cholesterol
Time frame: Change from baseline total cholesterol at 4 weeks
Total body fatness
Time frame: Change from baseline fat percentage at 4 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 16 Apr 2019.
- Background: PubMed 19083400Kajiyama S, Hasegawa G, Asano M, Hosoda H, Fukui M, Nakamura N, Kitawaki J, Imai S, Nakano K, Ohta M, Adachi T, Obayashi H, Yoshikawa T. Supplementation of hydrogen-rich water improves lipid and glucose metabolism in patients with type 2 diabetes or impaired glucose tolerance. Nutr Res. 2008 Mar;28(3):137-43. doi: 10.1016/j.nutres.2008.01.008.
- Background: PubMed 20216947Nakao A, Toyoda Y, Sharma P, Evans M, Guthrie N. Effectiveness of hydrogen rich water on antioxidant status of subjects with potential metabolic syndrome-an open label pilot study. J Clin Biochem Nutr. 2010 Mar;46(2):140-9. doi: 10.3164/jcbn.09-100. Epub 2010 Feb 24.
- 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.
- Derived from this study: PubMed 30982748Korovljev D, Stajer V, Ostojic J, LeBaron TW, Ostojic SM. Hydrogen-rich water reduces liver fat accumulation and improves liver enzyme profiles in patients with non-alcoholic fatty liver disease: a randomized controlled pilot trial. Clin Res Hepatol Gastroenterol. 2019 Nov;43(6):688-693. doi: 10.1016/j.clinre.2019.03.008. Epub 2019 Apr 11.
- Individual participant dataSharing planned: Undecided. IPD will be shared via Institutional repository
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen in people with Non-Alcoholic Fatty Liver Disease, run by University of Novi Sad, Faculty of Sport and Physical Education at 2 sites 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Liver fat content (time frame: Change from baseline liver triglycerides at 4 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 NCT03625362, which also lists 4 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 16 Apr 2019.