Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- serum concentration of Total Cholesterol (TC),
研究概览
简要总结
The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial: demonstrate potential to reduce total blood cholesterol more than 10% and/or total triglycerides more than 15%, as required by State food and drug administration (SFDA) regulation.
详细描述
The proposed clinical trial is a pilot randomized, double-blind, placebo controlled, parallel, multicenter study with three treatment groups.
The total number of 75 subjects should be enrolled to provide for a 20% dropout rate.
Subjects will be randomized into one of the following 3 groups:
- milk without sterols and hawthorn powder
- milk with 1.2g/d sterols and 8g/d hawthorn powder
- milk with 1.8g/d sterols and 8g/d hawthorn powder
The trial population will consist of female or male volunteers aged 18 - 65 years of age with primary mild to moderate hyperlipidemia documented by a serum cholesterol of 5.18-6.21mmol/L AND serum Triglycerides (TG): 1.7-5.65mmol/L , for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Chinese male or female 18 to 65 years old (inclusive). Fasting Serum TC: 5.18-6.21mmol/L (equals to 200-241 mg/dl) AND Serum TG: 1.7-5.65mmol/L (equals to 150- 500 mg/dl) for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.
- •Primary dyslipidemia.
- •The subject demonstrates an understanding of the given information and ability to record the requested data.
- •Having obtained his/her informed consent
排除标准
- •BMI above 32 kg/m2 ( morbid obesity).
- •Pregnant or lactating women or intent to get pregnant.
- •Menopause women on hormonal replacement therapy.
- •Familial hyperlipidemia.
- •Identified food allergy to dairy product or lactose intolerance.
- •Severe diseases in heart, liver, kidney or hematopoietic system before admission.
- •History of angina, myocardial infarction, coronary artery bypass, heart failure or other cardiovascular instability during the last 6 months.
- •History of diabetes, GI, renal, pulmonary, hepatic and biliary, hypothyroidism, mental disease no self-control capacity or no articulate.
- •Subject who are currently taking drugs that interfere with lipid profiles, including but not limited to statin, nicotinic acid, bile acid sequestrant, fibric acids, policosanol tablets.
- •Subject who has received any anti-hyperlipidemia medication in the past 4 weeks.
- •Subject who regularly takes supplements with the function of lipid reduction in the past 3 months or will take during the study (e.g. plant sterols, omega-3 fish oil, beta-glucan, nut-rich diet, soy protein, soluble oat fiber, red yeast rice or other cholesterol reducing functional ingredients).
- •In-patient hyperlipidemia subjects.
- •Alcohol > 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day.
- •Subject who cannot be expected to comply with the study procedures.
- •Subject who is currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
结局指标
主要结局
serum concentration of Total Cholesterol (TC),
时间窗: after 7 weeks of treatment.
次要结局
- other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.(at 4 and 7 weeks of treatment)
- phytosterol metabolism parameters(after 7 weeks of treatment)
- safety parameters(after 7 weeks of treatment)
- biomarkers of lipid oxidation and inflammation(after 7 weeks of treatment)
- predictive marker for cardiovascular disease(after 7 weeks of treatment)