NCT02908152已完成2 期
The Effect of Curcumin Supplement on Metabolic Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Patients
National Nutrition and Food Technology Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年2月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hepatic steatosis
研究概览
简要总结
The purpose of this study is to investigate the effects of curcumin supplement on metabolic factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes. Subjects will participate in 3 month, two group, randomized intervention, where one group (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare differences in outcomes between the two groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with type 2 diabetes based on ADA definition or who only take oral antidiabetic drug;
- •CAP score >263.
排除标准
- •Taking any kind of antibiotics two weeks before recruitment;
- •History of alcohol consumption;
- •pregnancy or lactation;
- •Professional athletes;
- •Other liver disease (viral/etc);
- •High dose synthetic estrogens, methotrexate, amiodarone, steroids, chloroquine, immunosuppressive drugs;
- •A history of Cardiovascular disease;
- •Renal disease, Celiac disease, Cirrhosis;
- •History of Upper GI surgery;
- •A history of hypothyroidism or Cushing's syndrome;
- •History of drug dependence;
- •Body mass index (BMI) ≥35 kg/m2;
- •A restrictive diet or weight change ≥ 5 kg during the 3months prior to study;
- •Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
- •Use of weight loss medications.
结局指标
主要结局
Hepatic steatosis
时间窗: [12 weeks]
measured by CAP score using Fibroscan
次要结局
- Glucose([12 weeks])
- HBA1C([12 weeks])
- AST([12 weeks])
- ALT([12 weeks])
研究者
Dr Azita Hekmatdoost
Principal Investigator
National Nutrition and Food Technology Institute
研究点 (1)
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