Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease

Not Applicable

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Hydrogen

• Registration Number: NCT03625362
• Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

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.

Study Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-10
• Study Start: 2018-09-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 L of tap water
Hydrogen	Hydrogen	1 L of hydrogen-rich water

Primary Outcome Measures

Name	Time	Method
Liver fat content	Change from baseline liver triglycerides at 4 weeks	MRS spectra for liver triglycerides

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	Change from baseline total cholesterol at 4 weeks	Level of total cholesterol in the blood
Total body fatness	Change from baseline fat percentage at 4 weeks	Fat percentage evaluated by BIA

Trial Locations

Locations (2)

Applied Bioenergetics Lab at Faculty of Sport and PE; 🇷🇸 Novi Sad, Vojvodina, Serbia

FSPE Applied Bioenergetics Lab; 🇷🇸 Novi Sad, Vojvodina, Serbia