Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Hydrogen-rich Water on Liver Fat Accumulation, Blood Lipids and Body Fatness in Patients With Non-alchoholic Fatty Liver Disease

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: Hydrogen
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogen<br>1 L of hydrogen-rich water | Dietary Supplement: Hydrogen<br>* Hydrogen-rich water<br>|
| Placebo Comparator: Placebo<br>1 L of tap water | Dietary Supplement: Placebo<br>* Tap water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fat content | MRS spectra for liver triglycerides | Change from baseline liver triglycerides at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Level of total cholesterol in the blood | Change from baseline total cholesterol at 4 weeks | 
| Total body fatness | Fat percentage evaluated by BIA | Change from baseline fat percentage at 4 weeks |