The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of Fibroblast Growth Factor-21 and Fetuin A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Hepatic histological features by Fibroscan
研究概览
简要总结
In this research, the investigators tested the effect of 12-week supplementation with soy isoflavones on non alcoholic fatty liver disease (NAFLD) management and the level of fibroblast growth factor-21 (FGF-21) and fetuin A as markers of NAFLD progression.
详细描述
Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge burden on health and economic systems. The aim of the present study was to investigate the effect of soy isoflavone intake on hepatic outcomes and the level of fibroblast growth factor-21 (FGF-21) and fetuin A in patients with NAFLD. Fifty patients with NAFLD were randomized to either receive two tablets of soy isoflavone (100 mg/d) or placebo. Dietary intakes, anthropometric parameters, the serum levels of liver function tests including alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT), FGF-21, fetuin A and hepatic histological features by Fibroscan assessed at study initiation and after week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The participants and investigator were blinded to study groups (double blinded study)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •without any history of allergy to soy or excessive consumption of soy products
- •without chronic diseases including renal, liver, heart, respiratory, cardiovascular, malignancies, auto immune disorders, cushing's syndrome, thyroid dysfunction, hepatitis, cirrhosis, biliary disorders, diabetes, gastrointestinal tract diseases affecting the gut absorption and psychiatric disorders considering as an obstacle for patients to prepare written informed consent;
- •hepatic steatosis grade 2 and higher with fibroscan confirmation (CAP > 260 dB/m);
- •without history of excessive alcohol drink (≥10 g/day);
- •without history of drug consumption with approved positive effects on NAFLD treatment (i.e. metformin, vitamin E, ursodeoxycholic acid, phenytoin, tamoxifen, lithium, corticosteroids and methotrexate) in last three months;
- •without the history of bariatric surgery or following weight loss diets within 6 months;
- •without history of smoking;
- •not being a pregnant or lactating woman
排除标准
- •consuming less than 90% of intended supplements.
- •unwillingness for study collaboration
结局指标
主要结局
Hepatic histological features by Fibroscan
时间窗: 12 weeks
The subject's hepatic histological features using Fibroscan (Echosense, France) assessed at study initiation and at week 12.
The Level of serum liver enzymes
时间窗: 12 weeks
The serum levels of alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT) measured through enzymatic methods by Delta Darman Part test kits (Delta darman part, Tehran, Iran) at study initiation and at the end of the trial
次要结局
- fibroblast growth factor-21 (FGF-21)(12 weeks)
- Fetuin A(12 weeks)
研究者
Asal Neshatbini Tehrani
Principal Investigator
Ahvaz Jundishapur University of Medical Sciences