KCT0008871已完成Unknown
A 12 week, Single-center, Randomized, Double-Blind, Placebo-Controlled, Parallel design Clinical Trial for the Evaluation of the Efficacy and safety of Lactiplantibacillus plantarum SKO-001 on Reducing Body Fat
试验速览
- 阶段
- Unknown
- 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
入排标准
- 年龄范围
- 19(Year) 至 64(Year)（—）
- 性别
- All
入选标准
- •1) Men and women between the ages of 19 and 65
- •2) Subjects with a body mass index of 25.0 kg/m^2 or more and less than 30.0 kg/m^2
- •3) Subjects who voluntarily decides to participate in this study and signs the Informed Consent Form
排除标准
- •1) Participants with a history of hypersensitivity to drugs, food ingredients, herbal extracts, dietary supplements, or lactobacillus
- •2) Participants currently undergoing treatment for severe cardiovascular, immune, respiratory, hepatomegaly, kidney and urinary system, nervous system, musculoskeletal system, psychotropic diseases and malignant tumors
- •3) Participants who are consuming prebiotics, probiotics, and postbiotics similar to this investigational product within 4 weeks prior to screening
- •4) Participants who have had participated in a commercial obesity program or treatment program for weight loss within the last three months prior to screening
- •5) Participants taking drugs (absorption inhibitors, appetite suppressants, beta Blockers, GLP-1 receptor agonist, health functional foods/supplements related to obesity improvement, psychiatric drugs such as depression, diuretics, contraceptives, steroids, female hormones) or diet foods that affect their weight within 3 months prior to screening
- •6) Participants with weight change of at least 10% within 3 months prior to screening
- •7) Participants who had undergone surgery such as gastronomy, intestinal resection, or other surgical procedures for weight loss within 6 months prior to screening
- •9) Participants who have liver disease or whose ALT or AST is more than 3 times the upper limit of normal
- •10) Participants who have renal disease or whose creatinine level is more than twice the upper limit of normal
- •11) Patients with uncontrolled hypertension(blood pressure over 160/100 mmHg or if medication has been changed or started anew due to hypertension within 3 months)
- •12) Participants who have a fasting blood sugar level of 126 mg/dl or higher, have been diagnosed with diabetes, or are taking oral hypoglycemic agents or insulin
- •13) Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion
- •14) Participants with a history of serious psychiatric illness (schizophrenia, epilepsy, anorexia, bulimia, etc.) or alcohol or the other drug abuse
- •15) Participants who are determined to be unable to exercise due to musculoskeletal disorders
- •16) Women who are pregnant, lactating, or planning to become pregnant during the trial
- •17) Participants who has a history of having participated in another trial or taking a test drug within 3 months prior to screening
- •18) Participants who are deemed inappropriate to participate in this study by the principal investigator (or delegated subinvestigator) for other reasons
研究者
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