Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects
- Conditions
- Primary Dyslipidemia
- Interventions
- Dietary Supplement: sterols and hawthorn powder
- Registration Number
- NCT02221973
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description milk with 1.2g/d sterols and 8g/d hawthorn powder sterols and hawthorn powder - milk without sterols and hawthorn powder sterols and hawthorn powder - milk with 1.8g/d sterols and 8g/d hawthorn powder sterols and hawthorn powder -
- Primary Outcome Measures
Name Time Method serum concentration of Total Cholesterol (TC), after 7 weeks of treatment.
- Secondary Outcome Measures
Name Time Method 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
phytosterol metabolism parameters after 7 weeks of treatment phytosterol metabolism parameters in fecal samples
safety parameters after 7 weeks of treatment safety parameters
biomarkers of lipid oxidation and inflammation after 7 weeks of treatment biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples
predictive marker for cardiovascular disease after 7 weeks of treatment assess predictive marker for cardiovascular disease by non-invasive vascular screening device
Trial Locations
- Locations (3)
Anzhen Hospital, Capital University of Medical Sciences
🇨🇳Beijing, China
Chao Yang 2nd Hospital
🇨🇳Beijing, China
Chui Yang Liu Hospital
🇨🇳Beijing, China