KCT0001611已完成未知
Human study for investigating the effectiveness and safety of yellow yeast rice on control of blood cholesterol
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 45(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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