A Randomized, Double-blind, Placebo-controlled Trial of Using Red Yeast Rice, Phytosterol Esters and Lycopene in Combination for Regulating Lipid Metabolism of Guangzhou Individuals With Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in levels of total cholesterol
研究概览
简要总结
The objective of this study is to evaluate the effect of using red yeast rice, phytosterol esters and lycopene in combination for 12 weeks on improving the glycolipid metabolism of Guangzhou individuals with dyslipidemia. Our hypothesis is that when compared with placebo, red yeast rice, phytosterol esters and lycopene together as supplements would lead to greater improvements in lipid metabolism (including lipid profiles and parameters ) in participants after 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 30-50 years old.
- •Non-obese individuals: 18.5 ≤ BMI <
- •Total cholesterol levels ranging from marginal increase to increase: 6.2> TC ≥ 5.2 mmol/L (200 mg/dL).
排除标准
- •Currently being pregnant or breast-feeding or planning to become pregnant.
- •Having severe complications of diabetes mellitus as well as any forms of cardiovascular diseases, tumor, liver diseases and kidney diseases.
- •History (past 3 months) of intake of lipid-lowering or anti-diabetic health care products.
- •Having hemorrhagic diathesis (high bleeding tendencies) or currently taking aspirin.
- •Unwilling/unable to draw blood due to physical/personal reasons.
- •History (past 1 month) of surgery.
- •History (past 1 month) of large amounts of oral or intravenous treatment of glucocorticoids (such as prednisone, methylprednisone, betamethasone, beclomethasone propionate, Dubossone, prednisone, hydrocodesone, dexamethasone).
- •History (past 2 weeks) of taking supplements containing red yeast rice, phytosterol ester or lycopene.
- •Unqualified outcomes of safety measures at baseline.
结局指标
主要结局
Change in levels of total cholesterol
时间窗: 12 weeks
At baseline, 4 weeks, 8 weeks and 12 weeks, bloods samples will be drawn and levels of total cholesterol will be determined in the two groups.
次要结局
未报告次要终点
研究者
Lili Yang
head of Department of Nutrition, School of Public Health, Sun Yat-sen University
Sun Yat-sen University