The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Effects of CoQ10 on lipid profile
研究概览
简要总结
In previous study the investigators found that CoQ10 can improve cholesterol efflux from macrophages in cell model, ApoE mice model and small-scale of healthy volunteers. In addition, CoQ10 has strong antioxidant activity and is an essential factor of mitochondria electron transport chain. So the investigators hypothesize that CoQ10 may have some health promotion effect on dyslipidemia, risk factor of atherosclerosis and other cardiovascular diseases. On this purpose, the investigators are going to recruit 150 dyslipidemia patients to supply CoQ10+vitamin E or CoQ10 alone or placebo in different doses for 24 weeks to explore the effects of CoQ10 on cholesterol efflux and lipid profiles on dyslipidemia.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects were considered to have dyslipidemia if they met 2 of the following 4 criteria:
- •fasting total cholesterol concentration>200 mg/dL,
- •fasting triglyceride concentration>150mg/dL,
- •fasting LDL-cholesterol concentrations>100 mg/dL, or
- •fasting HDL-cholesterol concentrations>40 mg/dL.
排除标准
- •history of CVD or other severe chronic disease or use of any drugs known to affect lipid metabolism.
- •use any antioxidant such as Vitamin E, vitamin C,Phytochemicals and coenzyme Q10 within two months before trial.
- •pregnant or lactating women
研究组 & 干预措施
combined group
each coenzyme Q10 vitamin E softgel contain CoQ 10 30mg + vitamin E 16mg; The subjects in this arm take 2 softgels after lunch and supper respectively per day. Total supplementation is 120mgCoQ10 and 64mg vitamin per day. The duration is 24 weeks.
干预措施: coenzyme Q10 vitamin E softgel (Dietary Supplement)
CoQ10 group
each softgel contain CoQ 10 30mg; The subjects in this arm take 2 softgels after lunch and supper respectively per day. Total supplementation is 120mgCoQ10 per day. The duration is 24 weeks.
干预措施: coenzyme Q10 softgel (Dietary Supplement)
placebo group
each softgel contain no vitamin E, no CoQ10; The subjects in this arm take 2 softgels after lunch and supper respectively per day. The duration is 24 weeks.
干预措施: placebo softgel (Dietary Supplement)
结局指标
主要结局
Effects of CoQ10 on lipid profile
时间窗: 6 months
Tg, Tc, LDL, HDL, APOA1,APOB
次要结局
- Effects of CoQ10 on blood glucose and insulin(6 mouth)
- Effects of CoQ10 on oxidative stress and inflammation(6 mouth)
研究者
zhangpeiwen
PhD candidate
Sun Yat-sen University