KCT0005652已完成未知
An 8-week, randomized, double-blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of Lactobacillus plantarum HAC01 on the postprandial glucose levels.
AtoGen0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 19?(Year) 至 70?(Year)（—）
- 性别
- All
入选标准
- •1) Aged 19 to 70 years
- •2) Isolated-impaired glucose tolerance (plasma glucose levels from 140 to 199 mg/dl two hours after a 75 g oral glucose consumption during an oral glucose tolerance test)
- •3) Voluntary agreement to participate in the clinical trials and provision of informed consent
排除标准
- •1) Fasting plasma glucose level < 90 mg/dl or = 140 mg/dl
- •2) HbA1c=7.0%
- •3) History of underlying type 1 or type 2 diabetes mellitus
- •4) Reduction of 10% weight within 3 months
- •5) Systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg
- •6) Administration of antibiotic within 2 weeks before screening visit
- •7) Intake of probiotics or fermented milk products (yogurt, cheese, etc.) within 2 weeks before screening visit
- •8) Administration of corticosteroids within 4 weeks before screening visit
- •9) Administration of hypoglycemic agents, anti-obesity drugs, lipid-lowering agents etc. within 3 months or intake of functional foods that affect blood glucose or obesity or lipid metabolism within 2 months before screening visit
- •10) Major medical illness such as cardiovascular, neurologic, hepatic, musculoskeletal system, psychiatric, endocrine system, immune, renal, malignant tumor and pulmonary disease etc.
- •11) History of alcohol or substance abuse
- •12) History of disease that can interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
- •13) Allergic or hypersensitivity to drug and any of the ingredients in the test products (probiotics)
- •14) Participation in other clinical trials within 3 months
- •15) AST or ALT > 3 fold of normal range or serum creatinine > 2.0 mg/dl
- •16) Female subjects of childbearing potential who are not willing to use appropriate contraception (except for surgery for female infertility)
- •17) Pregnant, planning to become pregnant, or breast-feeding
- •18) Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
研究者
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