Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat
2019年7月23日 更新者：Soo-Wan Chae、Chonbuk National University Hospital
A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat
This study was conducted to investigate the effects of daily supplementation of Soybean germ extract on decrease of body fat
研究概览
详细说明
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial.
80 subjects were randomly divided into Soybean germ extract 1,600 mg or placebo group.
The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index, etc.
研究类型
介入性
注册 (预期的)
80
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
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Jeollabuk-do
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Jeonju、Jeollabuk-do、大韩民国、54907
- 招聘中
- Clinical Trial Center for Functional Foods Chonbuk National University Hospital
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-
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
19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:
- age between 19 and 65 years
- BMI 25~29.9 kg/m^2
- After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Exclusion Criteria:
- Those who lost more than 10% of their weight within 3 months before the screening
- Those who take a product(body fat improvement health functional foods, birth control pills, steroids, female hormone) that affects your weight within 4 weeks prior to the screening
- Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- Diabetic patients taking oral hypoglycemic agents or insulin (based on screening subjects)
- A person with a history of clinically significant hypersensitivity to soybeans
- Those who have received antipsychotic medication within 2 months before screening
- Anyone with substance abuse or suspicion
- Those who participated in other clinical trials within 3 months before screening
- Systolic Blood Pressure(SBP) 180 mmHg, Diastolic Blood Pressure(DBP) 110 mmHg or more
- Menopausal woman
Laboratory test by show the following results
- Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- Serum Creatinine > 2.0 mg/dL
- Pregnancy or breast feeding
- Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
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：预防
- 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 |
|---|---|
|
实验性的：Soybean Germ Extract
Soybean Germ Extract 1,600 mg/day for 12 weeks.
|
Soybean Germ Extract 1,600 mg/day for 12 weeks.
|
|
安慰剂比较：Placebo
Placebo 1,600 mg/day for 12 weeks.
|
Placebo 1,600 mg/day for 12 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 |
|---|---|---|
|
身体脂肪量的变化
大体时间：基线和第 12 周
|
在研究基线和 12 周时测量身体脂肪量
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基线和第 12 周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes of percent body fat
大体时间：Baseline and 12 week
|
Measurement is made using dual energy X-ray absorptiometry (DEXA / Hologic Discovery, USA).
Left arm, right arm, left leg, right leg, trunk, total will be report percent body fat in %.
|
Baseline and 12 week
|
|
Changes of fat free mass
大体时间：Baseline and 12 week
|
Measurement is made using dual energy X-ray absorptiometry (DEXA / Hologic Discovery, USA).
Left arm, right arm, left leg, right leg, trunk, total will be report fat free mass in g.
|
Baseline and 12 week
|
|
Changes of Anthropometric indicate: body weight
大体时间：Screening, baseline and 12 week
|
Anthropometric indices were measured in study screening, baseline and 12 week.
Body weight in kg.
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Screening, baseline and 12 week
|
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Changes of Anthropometric indicate: body mass index
大体时间：Screening, baseline and 12 week
|
Anthropometric indices were measured in study screening, baseline and 12 week.
Weight/height^2 will be report body mass index in kg/m^2.
|
Screening, baseline and 12 week
|
|
Changes of Anthropometric indices: waist circumference, hip circumference
大体时间：Screening, baseline and 12 week
|
Anthropometric indices were measured in study screening, baseline and 12 week.
Waist circumference, hip circumference in cm.
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Screening, baseline and 12 week
|
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Changes of Anthropometric indicate: waist -hip circumference ratio
大体时间：Screening, baseline and 12 week
|
Anthropometric indices were measured in study screening, baseline and 12 week.
Waist circumference/hip circumference will be report waist -hip circumference ratio.
|
Screening, baseline and 12 week
|
|
Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol
大体时间：Baseline and 12 week
|
Lipid metabolism indicators(mg/dL) were measured in study baseline and 12 week.
|
Baseline and 12 week
|
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Changes of obesity-related hormones indicators: Adiponectin, Leptin
大体时间：Baseline and 12 week
|
obesity-related hormones indicators were measured in study baseline and 12 week
|
Baseline and 12 week
|
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Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 α(PGC-1 α)
大体时间：Baseline and 12 week
|
energy expenditure Indicators were measured in study baseline and 12 week
|
Baseline and 12 week
|
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)
2019年6月3日
初级完成 (预期的)
2020年2月28日
研究完成 (预期的)
2020年2月28日
研究注册日期
首次提交
2019年1月23日
首先提交符合 QC 标准的
2019年1月30日
首次发布 (实际的)
2019年2月1日
研究记录更新
最后更新发布 (实际的)
2019年7月24日
上次提交的符合 QC 标准的更新
2019年7月23日
最后验证
2019年7月1日
更多信息
与本研究相关的术语
其他研究编号
- NOVA-BF-SBG
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
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