Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Platelet function induced by collagen
研究概览
简要总结
Aim: to determine the effects of DHA supplementation:
- on the platelet function through their aggregation and the pathway of arachidonic acid metabolism
- on redox status on cells and plasma
- on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400 mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out period of 6 to 9 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Menopausal or aged between 55 and 75 years old
- •Recent HbA1c between 6.5-10%
- •Oral anti-diabetic drugs or insulin therapy
- •Hypertension or antihypertensive drug
排除标准
- •Excessive drinking
- •Post-menopausal hormonal treatment
- •Treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, NSAID
- •Secondary cardiovascular prevention
- •antioxidant using
- •Fish intake >2 times a week
- •Anemia <10g/L
- •Thrombopenia <110g/L
- •Creatinine clearance <30 ml/min and/or proteinuria >1g/L
研究组 & 干预措施
DHA - Sunflower oil
400 mg DHA supplementation by day for 2 weeks then placebo for 2 weeks after a wash out period of 6 to 9 weeks
干预措施: First period DHA (Dietary Supplement)
Sunflower oil - DHA
Placebo during 2 weeks then 400 mg DHA supplementation by day for 2 weeks after a wash out period for 6 to 9 weeks
干预措施: Second period DHA (Dietary Supplement)
结局指标
主要结局
Platelet function induced by collagen
时间窗: 4 blood sampling in 10 to 13 weeks
4 blood sampling are made during the time of study which expand from 10 weeks (washout period of 6 weeks) to 13 weeks (washout period of 9 weeks): * first at the beginning of the first period * second at the end of the period (2 weeks after beginning) * third at the beginning of the second period * fourth at the end of the period (2 weeks after beginning)
次要结局
- Evaluation of cellular and plasmatic redox status(4 blood sampling in 10 to 13 weeks)