KCT0008055已完成未知
A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Lactobacillus plantarum LMT1-48 on Reducing Body Fat
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 120
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 69(Year)（—）
- 性别
- All
入选标准
- •1) A person who is 19 years of age or older and under 70 years of age
- •2) Those with a body mass index (BMI) of 25 kg/m² or more and less than 30 kg/m² for visit 1 and visit 2
- •3) A person who agrees to participate in the human body application test and prepares a written consent form before the human body application test begins
排除标准
- •1) Serious cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary tract, kidney and urinary system, nervous system, mental,
- •A person who is currently being treated for infectious diseases, etc. (However, he/she may participate in the test at the discretion of the tester considering the condition of the person subject to the human body application test)
- •2) Those diagnosed with cancer within 5 years as of Visit 1 (excluding thyroid cancer, early cervical cancer (endothelial cancer))
- •3) Within 1 month (30 days) of visit 1, weight-affecting drugs (such as appetite suppressants, liposuction inhibitors, GLP-1 receptor agonists), psychiatric drugs such as depression and schizophrenia, beta-blockers, diuretics, contraceptives, thyroid hormones), hyperlipidemia drugs (including omega3), health-controlled, phytosanitary and dietary supplements
- •4) A person who has administered antibiotics and intestinal medications within two weeks as of Visit 1
- •5) A person who has administered or ingested probiotics, prebiotics, and lactobacillus products continuously (more than 4 times a week) within 2 weeks as of Visit 1
- •6) A person who has undergone obesity surgery within one year based on visit 1
- •7) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, measured after stabilization for 10 minutes)
- •8) Diabetes patients who have an empty stomach blood sugar of 126 mg/dL or higher or who are taking anti-diabetic drugs (e.g., oral hypoglycemic drugs, insulin, etc.)
- •9) Those with a TSH of not more than 0.1 µIU/mL or not more than 10 µIU/mL
- •10) A person whose creatinine is twice or more than the upper limit of the institution's normal limit
- •11) A person whose AST (GOT) or ALT (GPT) is three times or more than the upper limit of the normal limit of the implementing institution;
- •12) Alcohol use ? People with induced or central nervous disorders
- •13) A person who is deemed unable to exercise due to musculoskeletal disorders
- •14) A person who has experienced a weight change of 10% or more within 3 months as of Visit 1
- •15) A person who has participated in a commercial obesity program within three months as of Visit 1
- •16) A person who has participated in other interventional clinical trials (including human application tests) within 3 months of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of the personal application test
- •17) A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
- •18) A person who has a problem with food intake for human body application tests due to severe gastrointestinal disorders
- •19) A person who is sensitive to or allergic to food ingredients for this human body application test
- •20) A person who judges that the tester is inappropriate for other reasons
研究者
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