跳至主要内容
临床试验/NCT03625362
NCT03625362已完成不适用

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

University of Novi Sad, Faculty of Sport and Physical Education4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
4
主要终点
Liver fat content

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Body mass index > 25 kg/m2
  • Free of major diseases besides NAFLD
  • Must be able to give written informed consent

排除标准

  • Use of any dietary supplements within 4 weeks before study commences
  • Abnormal values for lab clinical chemistry (> 2 SD)

结局指标

主要结局

Liver fat content

时间窗: Change from baseline liver triglycerides at 4 weeks

MRS spectra for liver triglycerides

次要结局

  • Total cholesterol(Change from baseline total cholesterol at 4 weeks)
  • Total body fatness(Change from baseline fat percentage at 4 weeks)

研究者

发起方
University of Novi Sad, Faculty of Sport and Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验