Effect of Purified Anthocyanin on Oxidative Stress and Glycemic Control in Subjects With Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- Glycemic Control
研究概览
简要总结
Anthocyanins, the water-soluble compounds that make plants appear different colors, have been shown to prevent insulin resistance, reduce the blood glucose and oxidative stress in rodents. The purpose of our study is to evaluate a potential protective effect of purified anthocyanins supplement on type 2 diabetes mellitus patients.
详细描述
The study was designed as a randomized, double-blind label, interventional study on patients with T2DM. The eligible Participants are randomly assigned to control and Anthocyanins supplement group. During the 12 weeks trial period,the participants were instructed to consume two anthocyanin capsules or placebo capsules twice daily (30 min after breakfast and supper).
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:(1) Diabetes symptoms (polydipsia, polyphagia, polyuria, weight loss, skin itching, blurred vision and other acute metabolic network disorder that caused by high blood sugar)combined with random blood sugar ≥11.1 OR,(2)fasting plasma glucose(FPG)≥7.0 OR (3)2h blood sugar after oral glucose tolerance test(OGTT)≥ 11.1
- •Subject is between 25 and 75 years of age, inclusive.
- •Subject BMI is ≥18.5 kg/m2 and ≤35 kg/m2
排除标准
- •Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type
- •Subject that use exogenous insulin for glucose control.
- •Subject that has a history of diabetic ketoacidosis.
- •Subject that has coronary artery disease, mental disorder, cancer, cirrhosis, renal disease and hepatic disease.
- •Subject that has had operation less than six months prior to screening visit.
- •Subject that uses supplementation with vitamins or antioxidants.
结局指标
主要结局
Glycemic Control
时间窗: Twelve weeks
Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention
次要结局
- Biomakers related to oxidative stress(Twelve weeks)
- Blood lipids(Twelve weeks)
研究者
Di Li
PhD
Sun Yat-sen University