KCT0008095已完成未知
A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of PB1 on Reducing Body Fat
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
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) Aged 19 or older and younger than 65
- •2) Body mass index (BMI) is more than 25 kg/m²and 35 kg/m² or less
- •3) A person who agreed to participate in this Clinical Study and filled out the written informed consent form.
排除标准
- •1) Those currently undergoing treatment for urinary system, nervous system, mental, infectious diseases, malignant tumors, etc.
- •2) Drugs that affect weight within 1 month (30 days) of visit 1, {anti-obesity drugs (appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.), psychiatric drugs such as depression and schizophrenia, beta-blockers, diuretics, birth control pills, steroids}, health functional foods/supplements for weight control purposes, herbal medicines, and weight control formulas.
- •3) Taken hyperlipidemia drugs within 1 month (30 days) from Visit 1 or who have taken omega-3 within 2 weeks from Visit 1.
- •4) Taken antibiotics within 2 weeks of visit 1.
- •5) Consumed probiotics, prebiotics, synbiotics and fermented products continuously (more than 4 times a week) within 2 weeks from visit 1.
- •6) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg).
- •7) Diabetic patients with fasting blood sugar of 126 mg/dL or higher or taking antidiabetic drugs (oral hypoglycemic drugs, insulin, etc.)
- •8) A person with TSH is less than 0.1 µIU/mL or more than 10 µIU/mL
- •9) A person whose creatinine is more than twice the upper limit of the study institution.
- •10) A person whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of the study institution.
- •11) A person with alcohol use induced disorders or central nervous system disorders.
- •12) Judged to be unable to exercise due to musculoskeletal disorders.
- •13) A person who has had a weight change of 10% or more within 3 months from visit 1
- •14) Those who participated in a commercial obesity program within 3 months of visit 1
- •15) Those who have participated in another clinical trial within 1 month (30 days) of visit 1, or plan to participate in another clinical trial after the start of this Clinical trial.
- •16) Pregnant or lactating women and who plan to pregnant during this clinical trial.
- •17) A person who has sensitive or allergic with food ingredients in this clinical trial.
- •18) Who Judged unsuitable from the tester in this clinical trial.
研究者
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