KCT0006105招募中未知
A 12-week, Single-centre, Randomised, Double-blinded, Placebo-controlled Study of Fermented Vegetables-derived Lactobacillus plantarum ATG-K2 to Evaluate Efficacy and Safety on Body Fat Reduction
AtoGen0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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 60?(Year)（—）
- 性别
- All
入选标准
- •1. Adult men and women aged =19 and <60 years
- •2. BMI =25 kg/m2 and <30 kg/m2
- •3. Subjects who voluntarily decide to participate and sign the informed consent after being provided an explanation of this study
排除标准
- •1. Subjects with a history of hypersensitivity to drugs, food ingredients, or lactic-acid bacteria
- •2. Subjects who have had participated in a commercial weight loss program or other clinical trial within the last three months
- •3. Subjects taking drugs (absorption inhibitor, appetite suppressant, health functional foods/supplements related to obesity improvement, psychiatric drugs such as depression, diuretics, contraceptives, steroids, or female hormones) or diet foods that affect their weight within three months prior to screening
- •4. Subjects with intentional weight loss of at least 5% within three months prior to screening
- •5. Subjects who have undergone surgery, such as gastroplasty and intestinal resection, to lose weight within six months prior to screening
- •6. Subjects who are obese or overweight due to endocrine diseases such as hypothyroidism and Cushing's syndrome
- •7. Subjects with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last six months (However, those who are clinically stable may participate in the trial at the investigator's discretion)
- •8. Subjects with serious dysfunction of the liver (alanine and aspartate aminotransferase levels of 3 times the upper limit of normal) or kidney (creatinine > 2.0 mg/dL)
- •9. Uncontrolled hypertension patients (blood pressure = 160/100 mmHg or in the case of medication changed or started anew within three months)
- •10. Uncontrolled diabetic patients (Fasting blood glucose = 180 mg/dL or in the case of medication changed or started anew within three months)
- •11. Malignant tumor diagnosed within five years prior to screening
- •12. Pregnant or lactating subjects, or women with pregnancy plan during the study period
- •13. Subjects who are deemed unsuitable according to the investigator's opinion
研究者
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