KCT0008184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 ALLULOSE on Reducing Body Fat
Samyang0 个研究点目标入组 228 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 228
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 35 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) Persons currently being treated for severe cardiovascular, immune, respiratory, hepatometer, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious diseases, and malignant tumors.
- •2) A person who uses of weight-affecting drugs (drug inhibitors, fat absorption inhibitors, GLP-1 receptor agonists, depression and schizophrenia, beta-blockers, diuretics, contraceptives, steroids, female hormones), health functional foods/supplements for weight control, herbal medicine, and hyperlipidemia within one month (30 days) of visit 1.
- •3) 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)
- •4) Diabetes patients with HbA1c of greater than 6.5% or who are taking anti-diabetic drugs (such as oral hypoglycemic drugs, insulin, etc.).
- •5) Those with a triglyceride of 500 mg/dL or more
- •6) ii. Those with a TSH of 0.1 µIU/mL or less, or 10 µIU/mL or more
- •7) Those with a creatine level of at least twice the normal upper limit of the implementing institution.
- •8) A person whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the operator.
- •9) A person who has a problem in eating food for human application testing due to severe gastrointestinal disorders;
- •10) Alcohol use ? Those with induction disorders and central nervous disorders
- •11) A person who is deemed unable to exercise due to musculoskeletal disorders.
- •12) A person who has a weight change of 10% or more within 3 months based on visit 1
- •13) A person who has participated in a commercial obesity program within 3 months of visiting 1
- •14) A person who has participated in another interventional clinical trial (including the human body application test) within two 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
- •15) A person who is pregnant or who is lactating or has plans to conceive during this human body application test.
- •16) A person who is sensitive to or allergic to food ingredients for this human body application test
- •17) Those who have used intestinal agents and antibiotics within two weeks of visit 1 (limited to those who collect feces for fecal mycelium analysis)
- •18) Those who have consumed probiotics, prebiotics, and lactic acid bacteria products continuously (at least four times a week) within two weeks of visit 1 (limited to those who do collection for fecal mycology analysis)
研究者
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