Primary Dyslipidemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTsterols and hawthorn powder
there are two dose level of sterols (1.2g/d; 1/8g/d)
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum concentration of Total Cholesterol (TC), | after 7 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc. | at 4 and 7 weeks of treatment | other lipid and lipoprotein parameters in serum samples |
| biomarkers of lipid oxidation and inflammation | after 7 weeks of treatment | biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples |
| phytosterol metabolism parameters | after 7 weeks of treatment | phytosterol metabolism parameters in fecal samples |
| predictive marker for cardiovascular disease | after 7 weeks of treatment | assess predictive marker for cardiovascular disease by non-invasive vascular screening device |
| safety parameters | after 7 weeks of treatment | safety parameters |
Countries
China
Outcome results
None listed