Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Hydrogen
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Body mass index > 25 kg/m2
- Free of major diseases besides NAFLD
- Must be able to give written informed consent
Exclusion Criteria:
- Use of any dietary supplements within 4 weeks before study commences
- Abnormal values for lab clinical chemistry (> 2 SD)
Sites / Locations
- Applied Bioenergetics Lab at Faculty of Sport and PE
- FSPE Applied Bioenergetics Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrogen
Placebo
Arm Description
1 L of hydrogen-rich water
1 L of tap water
Outcomes
Primary Outcome Measures
Liver fat content
MRS spectra for liver triglycerides
Secondary Outcome Measures
Total cholesterol
Level of total cholesterol in the blood
Total body fatness
Fat percentage evaluated by BIA
Full Information
NCT ID
NCT03625362
First Posted
August 6, 2018
Last Updated
April 15, 2019
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT03625362
Brief Title
Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease
Official Title
Effects of Hydrogen-rich Water on Liver Fat Accumulation, Blood Lipids and Body Fatness in Patients With Non-alchoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrogen
Arm Type
Experimental
Arm Description
1 L of hydrogen-rich water
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 L of tap water
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrogen
Intervention Description
Hydrogen-rich water
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Tap water
Primary Outcome Measure Information:
Title
Liver fat content
Description
MRS spectra for liver triglycerides
Time Frame
Change from baseline liver triglycerides at 4 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol
Description
Level of total cholesterol in the blood
Time Frame
Change from baseline total cholesterol at 4 weeks
Title
Total body fatness
Description
Fat percentage evaluated by BIA
Time Frame
Change from baseline fat percentage at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Body mass index > 25 kg/m2
Free of major diseases besides NAFLD
Must be able to give written informed consent
Exclusion Criteria:
Use of any dietary supplements within 4 weeks before study commences
Abnormal values for lab clinical chemistry (> 2 SD)
Facility Information:
Facility Name
Applied Bioenergetics Lab at Faculty of Sport and PE
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
FSPE Applied Bioenergetics Lab
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be shared via Institutional repository
Citations:
PubMed Identifier
19083400
Citation
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.
Results Reference
background
PubMed Identifier
20216947
Citation
Nakao 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.
Results Reference
background
PubMed Identifier
28560519
Citation
Korovljev 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.
Results Reference
background
PubMed Identifier
30982748
Citation
Korovljev 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.
Results Reference
derived
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Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease
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