Primary Dyslipidemia Clinical Trial
Official title:
Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01256476 -
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
|
Phase 4 |