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Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03625362
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Novi Sad, Faculty of Sport and Physical Education

Study Description
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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

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Dietary Supplement: Hydrogen Dietary Supplement: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Hydrogen-rich Water on Liver Fat Accumulation, Blood Lipids and Body Fatness in Patients With Non-alchoholic Fatty Liver Disease
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydrogen
1 L of hydrogen-rich water
 Dietary Supplement: Hydrogen
Hydrogen-rich water
Placebo Comparator: Placebo
1 L of tap water
 Dietary Supplement: Placebo
Tap water


Outcome Measures
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Primary Outcome Measures :
  1. Liver fat content [ Time Frame: Change from baseline liver triglycerides at 4 weeks ]
    MRS spectra for liver triglycerides


Secondary Outcome Measures :
  1. Total cholesterol [ Time Frame: Change from baseline total cholesterol at 4 weeks ]
    Level of total cholesterol in the blood

  2. Total body fatness [ Time Frame: Change from baseline fat percentage at 4 weeks ]
    Fat percentage evaluated by BIA


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625362


Locations
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Serbia
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, Serbia, 21000
FSPE Applied Bioenergetics Lab
Novi Sad, Vojvodina, Serbia, 21000
Sponsors and Collaborators
University of Novi Sad, Faculty of Sport and Physical Education
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Novi Sad, Faculty of Sport and Physical Education
ClinicalTrials.gov Identifier: NCT03625362    
Other Study ID Numbers: 0417-HRW/2018
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be shared via Institutional repository

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases