KCT0002934已完成未知
Human trial to evaluate the efficacy and safety of Lactobacillus acidophilus NS1 on cholesterol improvement
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 100
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
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Subject who voluntarily agree to participate and signs informed consent form
- •2) Age=20 years
- •3) 200 mg/dL =Total cholesterol<240 mg/d
排除标准
- •1) Subjects who had consistently consumed the drug related to lipid metabolism (ex. statin, ezetimibe, diuretics, fibrate, beta blocker, acetylsalicylic acid, bile acid-binding resins, etc.) or oriental medicine within 1 month before the first visit, except for the subject who have taken thiazide among the diuretics or beta blockers without change of dose during last one year and expected not to change the dosage during the study period.
- •2) Following diseases:
- •- Familial hypercholesterolemia, past history of myocardial infarction or stroke
- •- Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg)
- •- Uncontrolled diabetes (fasting glucose level = 180 mg/dL)
- •- Liver dysfunction (AST, ALT = 3 X upper limit of normal range)
- •- Renal dysfunction (serum creatinine = 1.4 mg/dL)
- •- Gastrointestinal disease, autoimmune disease, endocrine disease (hyperthyroidism, hypothyroidism, etc), malignant tumor
- •3) Triglyceride = 300 mg/dL
- •4) Women receiving hormone therapy
- •5) Subjects who consumed the functional food related to lipid metabolism within 1 month before the first visit consistently (example: plant sterol, w-3 fatty acid, psyllium husk, aloe, chitosan, onion extract, dietary fiber, etc)
- •6) BMI (Body Mass Index) < 18.5 kg/m2 or = 35.0 kg/m2
- •7) Subjects who are controlling body weight or subjects who have changed of body weight more than 10% within 6 months before the first visit
- •8) Heavy smoker (= 20 cigarettes / day)
- •9) Subjects with alcoholism or subjects who consume of alcohol more than 350g per week (example: soju about 6 bottles/week or 6 glasses/day)
- •10) Excessive exercise (= 10 hours / week)
- •11) Participation in other clinical study within 1 month before the first visit
- •12) Subjects who are hypersensitive to probiotics
- •13) Pregnant or lactating women
- •14) Inappropriate subject decided by the investigator
研究者
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