Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease

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

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Dietary supplement: Hydrogen; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • FSPE Applied Bioenergetics Lab
    • Novi Sad, Vojvodina, Serbia, 21000
      • Applied Bioenergetics Lab at Faculty of Sport and PE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 0417-HRW/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD will be shared via Institutional repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No