Study for evaluation of cholesterol lowering effect, dose and safety of Bifidobacterium breve IDCC 4401
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003040
- Lead Sponsor
- Ildong pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
1) who agree to participate and consent
2) age of 20 or greater
3) 100mg/dl <= Low density lipoprotein cholesterol <150 mg/dl
1) use of lipid modifying drug within one month 2) cardiovascular disease, uncontrolled hypertension (systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg) , uncontrolled diabetes mellitus (fasting blood glucose >=180mg/dL)AST or ALT>= 3 x upper limit of reference value, serum creatinine >= 1.4 mg/dL, Gastrointestinal disease, autoimmune diesase, endocrine disease (hyper or hypothyroidism), malignancy 3) triglyceride >= 500 mg/dL 4) regular use of functional food altering lipid profiles within 1 month (phytosterol, omega-3, dietary fiber etc) 5) alcohol dependency 6) who participate other clinical trial within one month 7) hypersensitivity to probiotics 8) pregnancy or lactating women 9) person who is inappropriate to participate study determined by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes of LDL cholesterol;adverse reaction, vital sign, ECG, blood chemistry, urinalysis
- Secondary Outcome Measures
Name Time Method lipid profiles (triglyceride, total cholesterol, HDL-cholesterol, VLDL-cholesterol, non HDL-cholesterol, Apo AI, apo AII, apo B, apo E - total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, non HDL-cholesterol/HDL-cholesterol, LDL-cholesterol/Apo B, Apo B/Apo AI - Lp(a), oxidized LDL;highly sensitive C-reactive protein;bowel habit changes and Bristol stool scale