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Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease

U

University of Novi Sad, Faculty of Sport and Physical Education

Status

Completed

Conditions

Non-Alcoholic Fatty Liver Disease

Treatments

Dietary Supplement: Hydrogen
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03625362
0417-HRW/2018

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

10 participants in 2 patient groups, including a placebo group

Hydrogen
Experimental group
Description:
1 L of hydrogen-rich water
Treatment:
Dietary Supplement: Hydrogen
Placebo
Placebo Comparator group
Description:
1 L of tap water
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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