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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects

Conditions
-----------------
Primary Dyslipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: sterols and hawthorn powder


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: milk with 1.2g/d sterols and 8g/d hawthorn powder<br> | Dietary Supplement: sterols and hawthorn powder<br>* there are two dose level of sterols (1.2g/d; 1/8g/d)<br>|
| Experimental: milk with 1.8g/d sterols and 8g/d hawthorn powder<br> | Dietary Supplement: sterols and hawthorn powder<br>* there are two dose level of sterols (1.2g/d; 1/8g/d)<br>|
| Active Comparator: milk without sterols and hawthorn powder<br> | Dietary Supplement: sterols and hawthorn powder<br>* there are two dose level of sterols (1.2g/d; 1/8g/d)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum concentration of Total Cholesterol (TC), |  | after 7 weeks of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc. | other lipid and lipoprotein parameters in serum samples | at 4 and 7 weeks of treatment | 
| biomarkers of lipid oxidation and inflammation | biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples | after 7 weeks of treatment | 
| phytosterol metabolism parameters | phytosterol metabolism parameters in fecal samples | after 7 weeks of treatment | 
| predictive marker for cardiovascular disease | assess predictive marker for cardiovascular disease by non-invasive vascular screening device | after 7 weeks of treatment | 
| safety parameters | safety parameters | after 7 weeks of treatment |