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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
there are two dose level of sterols (1.2g/d; 1/8g/d)
Anzhen Hospital, Capital University of Medical Sciences
Beijing, China
Chao Yang 2nd Hospital
Beijing, China
Chui Yang Liu Hospital
Beijing, China
serum concentration of Total Cholesterol (TC),
Time frame: after 7 weeks of treatment.
other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.
other lipid and lipoprotein parameters in serum samples
Time frame: 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
Time frame: after 7 weeks of treatment
phytosterol metabolism parameters
phytosterol metabolism parameters in fecal samples
Time frame: after 7 weeks of treatment
predictive marker for cardiovascular disease
assess predictive marker for cardiovascular disease by non-invasive vascular screening device
Time frame: after 7 weeks of treatment
safety parameters
safety parameters
Time frame: after 7 weeks of treatment
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