IRCT20220801055597N1招募中3 期
Effects of soy isoflavones on metabolic profile, liver enzymes, hepatic fibrosis, inflammatory markers and total antioxidant capacity in patients with non-alcoholic fatty liver disease, double blind randomized clinical trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •18-75 years old
- •Willingness to participate in study
- •The concentration of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) shall be more than 1.5 fold of the maximum normal level.
- •With evidence of non alcoholic fatty liver disease in Fibroscan (CAP score>260)
- •Without a history of alcohol consumption or consuming alcohol less than 10 grams per day in women and less than 20 grams per day in men.
- •Not taking drugs that affect blood lipids, blood sugar and blood pressure, vitamin E and ursodioxycholic acid (UDCA) and hepatotoxic drugs such as phenytoin, amoxifen, lithium, methotrexate, amiodarone, tamoxifen, corticosteroids, valproate, antiviral drugs, etc. ..
- •Without a history of other diseases, chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, autoimmune diseases, cancer and hereditary disorders affecting the liver (iron or copper storage disease , etc.).
- •Without a history of celiac disease, diabetes, cardiovascular diseases, lung disease, digestive disease affecting food absorption and kidney disease.
- •Without a history of weight loss surgery in the past year or a history of adherence to a weight loss diet in the last 6 months
- •Without a history of thyroid disorder
- •Not taking fiber and soy supplements in the last 3 months
- •Without a history of smoking (cigarettes and other tobacco products)
- •Not regular consumption of soy or soy products in the diet (regular consumption means: consuming more than 30 grams (more than 2 tablespoons) per month)
- •Without a history of liver cirrhosis or not being classified in F4 group
排除标准
- •Pregnancy and breastfeeding
- •History of breast cancer
- •Consuming levothyroxine, warfarin and iron
- •History of allergy to soy and its products
研究者
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