Efficacy Evaluation of Dai Dai Flower on Body Weight
2021年8月3日 更新者：TCI Co., Ltd.
To assess the Dai Dai flower extract on body weight control
研究概览
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Taichung、台湾、404
- China Medical University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy male or female aged between 20 and 60 years old
- Body mass index (BMI) ≥ 24 (kg/m^2) or body fat mass ≥ 25%
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study
- Participate weight control or fat loss human studies before 3 months of this study
- History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting).
- Person who has received major surgery or bariatric surgery (according to medical history).
- Person who has received constant drug use.
- People with mental illness
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂饮料
|
consume 1 bottle (50 mL) per day for 8 weeks
|
|
实验性的：Dai Dai flower drink
|
consume 1 bottle (50 mL) per day for 8 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change of body weight
大体时间：Change from Baseline body weight at 8 weeks
|
The body weight (kg) was assessed by InBody.
|
Change from Baseline body weight at 8 weeks
|
|
The change of BMI
大体时间：Change from Baseline BMI at 8 weeks
|
The BMI was assessed by InBody.
|
Change from Baseline BMI at 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change of body fat mass
大体时间：Change from Baseline body fat mass at 8 weeks
|
The body fat mass (kg) was assessed by InBody.
|
Change from Baseline body fat mass at 8 weeks
|
|
The change of visceral fat mass
大体时间：Change from Baseline visceral fat mass at 8 weeks
|
The visceral fat mass (kg) was assessed by InBody.
|
Change from Baseline visceral fat mass at 8 weeks
|
|
The change of waist-hip ratio
大体时间：Change from Baseline waist-hip ratio at 8 weeks
|
The waist-hip ratio was assessed by measuring tape.
|
Change from Baseline waist-hip ratio at 8 weeks
|
|
The change of basal metabolic rate
大体时间：Change from Baseline basal metabolic rate at 8 weeks
|
The basal metabolic rate was assessed by InBody.
|
Change from Baseline basal metabolic rate at 8 weeks
|
|
The change of AST
大体时间：Change from Baseline AST at 8 weeks
|
Venous blood was sampled to measure concentrations of aspartate transaminase (AST)
|
Change from Baseline AST at 8 weeks
|
|
The change of ALT
大体时间：Change from Baseline ALT at 8 weeks
|
Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT)
|
Change from Baseline ALT at 8 weeks
|
|
The change of Creatinine
大体时间：Change from Baseline creatinine at 8 weeks
|
Venous blood was sampled to measure concentrations of creatinine
|
Change from Baseline creatinine at 8 weeks
|
|
The change of BUN
大体时间：Change from Baseline BUN at 8 weeks
|
Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN)
|
Change from Baseline BUN at 8 weeks
|
|
The change of fasting glycemia
大体时间：Change from Baseline fasting glycemia at 8 weeks
|
Venous blood was sampled to measure concentrations of fasting glycemia
|
Change from Baseline fasting glycemia at 8 weeks
|
|
The change of total cholesterol
大体时间：Change from Baseline total cholesterol at 8 weeks
|
Venous blood was sampled to measure concentrations of total cholesterol
|
Change from Baseline total cholesterol at 8 weeks
|
|
The change of triglyceride
大体时间：Change from Baseline triglyceride at 8 weeks
|
Venous blood was sampled to measure concentrations of triglyceride
|
Change from Baseline triglyceride at 8 weeks
|
|
The change of HDL-cholesterol
大体时间：Change from Baseline HDL-cholesterol at 8 weeks
|
Venous blood was sampled to measure concentrations of HDL-cholesterol
|
Change from Baseline HDL-cholesterol at 8 weeks
|
|
The change of LDL-cholesterol
大体时间：Change from Baseline LDL-cholesterol at 8 weeks
|
Venous blood was sampled to measure concentrations of LDL-cholesterol
|
Change from Baseline LDL-cholesterol at 8 weeks
|
|
The change of insulin
大体时间：Change from Baseline insulin at 8 weeks
|
Venous blood was sampled to measure concentrations of insulin
|
Change from Baseline insulin at 8 weeks
|
|
The change of adiponectin
大体时间：Change from Baseline adiponectin at 8 weeks
|
Venous blood was sampled to measure concentrations of adiponectin
|
Change from Baseline adiponectin at 8 weeks
|
|
The change of leptin
大体时间：Change from Baseline leptin at 8 weeks
|
Venous blood was sampled to measure concentrations of leptin
|
Change from Baseline leptin at 8 weeks
|
|
The change of IFN-γ
大体时间：Change from Baseline IFN-γ at 8 weeks
|
Venous blood was sampled to measure concentrations of IFN-γ
|
Change from Baseline IFN-γ at 8 weeks
|
|
The change of IL-2
大体时间：Change from Baseline IL-2 at 8 weeks
|
Venous blood was sampled to measure concentrations of IL-2
|
Change from Baseline IL-2 at 8 weeks
|
|
The change of IL-1beta
大体时间：Change from Baseline IL-1beta at 8 weeks
|
Venous blood was sampled to measure concentrations of IL-1beta
|
Change from Baseline IL-1beta at 8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月4日
初级完成 (实际的)
2021年3月6日
研究完成 (实际的)
2021年6月15日
研究注册日期
首次提交
2020年12月29日
首先提交符合 QC 标准的
2020年12月29日
首次发布 (实际的)
2021年1月5日
研究记录更新
最后更新发布 (实际的)
2021年8月4日
上次提交的符合 QC 标准的更新
2021年8月3日
最后验证
2021年8月1日
更多信息
与本研究相关的术语
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.