KCT0008119已完成未知
A 12 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Lactobacillus plantarum LRCC5282 on Reducing Body Fat
otte Chilsung Beverage0 个研究点目标入组 120 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
- 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 65(Year)（—）
- 性别
- All
入选标准
- •1) A person who is 19 years of age or older and 65 years of age or younger
- •2) Those with a body mass index (BMI) of 25 kg/m2 or more and less than 30 kg/m2 in Visit 1 and Visit 2
- •3) A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.
排除标准
- •1) Severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, mental, infectious disease, and malignant tumor can participate in the test at the discretion of the tester.
- •2) Within one month (30 days) of visit, weight-affecting drugs (obesity drugs, liposuction inhibitors, GLP-1 receptor agents, etc.), psychotropic drugs such as depression and schizophrenia, beta-blockers, diuretics, contraceptives, steroids, female hormones, thyroid hormones), health functional foods/supplements for weight control purposes, and herbal medicine.
- •3) A person who has used an intestinal medicine within two weeks based on visit 1.
- •4) A person who has consumed probiotics, prebiotics, and lactobacillus products continuously (more than four times a week) within two weeks of visiting.
- •5) A person who has undergone obesity surgery within one year based on visit 1.
- •6) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest for those subject to human application tests)
- •7) Diabetes patients with fasting blood sugar of 126 mg/dL or higher or taking anti-diabetic drugs (such as oral hypoglycemic drugs, insulin, etc.).
- •8) Those whose TSH is outside the normal range of the implementing institution (however, in consideration of the condition of the person subject to the human body application test) may participate in the test at the discretion of the tester.)
- •9) Those with a creatine level of at least twice the normal upper limit of the implementing institution.
- •10) Those whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the agency.
- •11) Alcohol use ? Those with induction disorders and central nervous disorders
- •12) A person who is deemed unable to exercise due to musculoskeletal disorders.
- •13) A person who has a weight change of 10% or more within three months based on visit 1
- •14) A person who has participated in a commercial obesity program within 3 months of visiting 1
- •15) A person who has participated in another interventional clinical trial (including the human body application test) within 3 months of visit 1 or plans to participate in another interventional clinical trial (including the human body application test) after the start of this human body application test
- •16) A person who is pregnant or who is lactating or has plans to conceive during this human body application test.
- •17) A person who has a problem eating food for human application testing due to severe gastrointestinal disorders
- •18) A person who is sensitive to or allergic to food ingredients for this human body application test
- •19) A person who is deemed inappropriate by the tester for other reasons.
研究者
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