Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects
Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects
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.
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.