effect of a low fat milk product on lipids profile in dyslipidemia subjects

Conditions: Primary Dyslipidemia

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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.