NCT02030977已完成2 期
The Effects of Resveratrol Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Dr Azita Hekmatdoost0 个研究点目标入组 50 人开始时间: 2012年6月1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
- 主要终点
- Alaninaminotransferase(ALT)
研究概览
简要总结
To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older;
- •Evidence of nonalcoholic steatohepatitis with steatosis grade higher or equal to 1 in ultrasonography;
- •No history of Alcohol consumption or consuming less than 10 grams alcohol per day in women and less than 20 grams per day in men;
- •Absence of other liver disorders, malignancies, cardiovascular, respiratory, and kidney disorders;
- •Absence of pregnancy or lactation;
- •Absence of taking any medications in the past three months;
- •Absence of weight loss in the recent three months;
- •Absence of endocrine and metabolism disorders.
排除标准
- •Weight loss more than 10% of baseline body weight during the intervention period.
- •Pregnancy;
- •Disliking to continue the study.
结局指标
主要结局
Alaninaminotransferase(ALT)
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
PI
National Nutrition and Food Technology Institute
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