Anthocyanin Supplementation Improves Blood Lipids in a Dose-response Manner in Subjects With Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Anthocyanins dose-dependently improved blood lipids in patients with dyslipidemia.
研究概览
简要总结
In order to study the effect of anthocyanins on the improvement of glucose and lipid metabolism, randomized intervention trials were conducted to compare the effects of anthocyanins on the improvement of glucose and lipid metabolism in different dose groups.To explore the best dose of anthocyanins for the prevention and treatment of anthocyanin metabolic diseases provide an important scientific basis.
详细描述
In order to study the effect of anthocyanins on the improvement of glucose and lipid metabolism, randomized controlled trials were conducted to enrolled 300 patients with dyslipidemia. The subjects were divided into 0 mg / d, 40 mg / d, 80 mg / d, 320 mg/ d five dose groups, intervention for 12 weeks, comparing different doses of anthocyanins on glucose and lipid metabolism.To explore the best dose of anthocyanins for the prevention and treatment of anthocyanin metabolic diseases provide an important scientific basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyslipidemia
- •Subjects with dyslipidemia who also have prediabetes
- •The age between 35 and 70 years old
排除标准
- •intake of any medicine that affect lipid and glucose metabolism currently or in the preceding 6 months
- •dietary supplementation with phytochemicals including anthocyanins in the preceding 2 months
- •history of acute or chronic infectious disease, autoimmune disease, cancer, traumatic injury, or surgery in the preceding 1 month
- •history of severe chronic disease including AS and CVD, liver or renal dysfunction, and lactation or pregnancy
- •Pregnant woman and Breast Feeding Women
研究组 & 干预措施
placebo
The placebo capsules only contained pullulan and maltodextrin.During the trial period, the participants were instructed to consume 2 Medox® placebo capsules twice daily (30 min after breakfast or supper).
干预措施: Medox® Anthocyanin capsules (Drug)
40mg/d anthocyanins
Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum). To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume one Medox® anthocyanin capsules and one Medox® placebo capsules 30 min after breakfast and consume two Medox® placebo capsules 30 min after supper.The anthocyanin capsules (40 mg anthocyanins per capsule) will provid a total daily intake of 40 mg anthocyanins.
干预措施: Medox® Anthocyanin capsules (Drug)
80mg/d anthocyanins
Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum).To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume one Medox® anthocyanin capsules and one Medox® placebo capsules 30 min after breakfast and consume two Medox® placebo capsules 30 min after supper.The anthocyanin capsules (80 mg anthocyanins per capsule) will provid a total daily intake of 80 mg anthocyanins.
干预措施: Medox® Anthocyanin capsules (Drug)
320mg/d anthocyanins
Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum).To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume two Medox® anthocyanin capsules 30 min after breakfast and after supper.The anthocyanin capsules (80 mg anthocyanins per capsule,4 per day) will provid a total daily intake of 320 mg anthocyanins.
干预措施: Medox® Anthocyanin capsules (Drug)
结局指标
主要结局
Anthocyanins dose-dependently improved blood lipids in patients with dyslipidemia.
时间窗: 12 weeks
After 12 weeks intervention of anthocyanins, serum lipid profiles were measured at baseline, at 6 weeks, and at the end of 12 weeks.
次要结局
- Anthocyanin supplementation improves cholesterol efflux capacity in a dose-response manner in subjects with dyslipidemia(12 weeks)
- Anthocyanins supplementation improve anti-oxidative and anti-inflammation capacity in a dose-response manner in subjects with dyslipidemia.(12 weeks)
- Anthocyanins supplementation attenuate platelet hyperreactivity in a dose-response manner in subjects with dyslipidemia.(12 weeks)
研究者
Zhanghy
Principal Investigator
Sun Yat-sen University