NCT01940263已完成早期 1 期
Effects of Purified Anthocyanin on Oxidative and Inflammatory Markers in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial
Shaoguan University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Biomarkers related to oxidative stress
研究概览
简要总结
Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.
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, 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
- 否
入选标准
- •BMI [body weight divided by height squared (in kg/m2)] > 23,
- •lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and
- •the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.
排除标准
- •overuse of alcohol,
- •viral hepatitis,
- •type 1 or 2 diabetes,
- •gastrointestinal or connective diseases,
- •chronic pancreatitis,
- •liver cirrhosis,
- •kidney stones, or renal failure;
- •use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation;
- •supplementation with vitamins or antioxidants
结局指标
主要结局
Biomarkers related to oxidative stress
时间窗: Twelve weeks
plasma total antioxidant capacity; plasma levels of protein carbonyl groups
次要结局
- Biomarkers related to inflammation(Twelve weeks)
研究者
研究点 (1)
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