Human study for investigating the effectiveness and safety of yellow yeast rice on control of blood cholesterol
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001611
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
1) Subject who voluntarily agrees to participate and sign in informed consent form
2) Man and postmenopausal women (45 years = Age )
3) 18 = BMI (Body Mass Index) = 30 kg/m2
4) Fasting LDL-cholesterol level = 130mg/dL
5) Fasting triglyceride level< 300mg/dL
1) Subjects who consistently consumed the drugs related to lipid metabolism (lipid-lowering drug, antihypertensive drug, weight-loss drug etc. examples: statin, fibrate, diuretics, ezetimibe, beta blocker, blocking agent and acetylsalicylic acid, bile acid-binding resins) or inflammation metabolism within 4 weeks before the first visit
2) Subjects who consumed the functional food (lipid metabolism or inflammation) or food (plantsterol, w-3 fatty acid, aloe, chitosan, extract of onion etc.) within 4 weeks before the first visit
3) Subjects who controlling body weight or subjects who have changed of body weight more than 10% within 6 month before the first visit
4) Following diseases :
- Subjects who had a diagnosis of myocardial infarction, stroke, hypertension
- Diabetes or subjects who fasting glucose level = 126mg/dL at screening
- Liver dysfunction (AST, ALT = 2.5 X upper limit of normal range)
- Renal dysfunction (serum creatinine = 1.4mg/dL)
- Chronic inflammatory bowel disease
- Autoimmune disease, hyperthyroidism, hypothyroidism or malignant tumor
5) Women receiving hormone therapy
6) Chronic smoker (= 20 cigarettes / day)
7) Alcoholic subjects or subjects who consume of alcohol more than 140g per week (example: soju about 2.5 bottles/week, about 2.5 glasses/day)
8) Excessive exercise (= 10 hours / week)
9) Participation in other human study within 4 weeks before the first visit
10) Subjects sensitive to test materials
11) Any condition that the principal investigator believes may put the subjects at undue risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood lipid profiles
- Secondary Outcome Measures
Name Time Method Markers of blood circulation