Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The changes of fasting blood glucose of the subjects
研究概览
简要总结
InnoSlim® has been studied for enhancing metabolic functions whereas many lab studies have demonstrated the potential efficacy of InnoSlim® for the blood sugar and blood lipids regulation. There has been no relevant human study on InnoSlim® on blood sugar and blood lipids regulation. There have reported that 2018 estimating the total costs of diagnosed diabetes have risen to $327 billion in 2017 from $245 billion in 2012. Although pharmacological methods have been developed to treat diabetes, these treatments can be costly and are not without potential adverse effects. The development of dietary agents for the prevention of diabetes could represent a cost-effective and safe means to deal with this growing public health crisis.
详细描述
In this study, the investigators are investigating the effects of InnoSlim® on blood sugar and blood lipids regulation in humans. The testing sample is orally administrated to participants with pre-diabetes and hyperlipidemia humans, the efficacy parameters of blood sugar, lipid profile and other parameters, as well as adverse effects to the healthy individual, are screened during the trial, the significant difference is shown and no adverse effect reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants age 20 years and above.
- •Participant has provided written and dated informed consent to participate in the study.
- •Participant is willing and able to comply with the study.
- •Participants blood sugar (100≤ fasting blood glucose ≤ 125 mg/dL and 5.7%≤HbA1c ≤ 6.4% ) and Total cholesterol ≥200 mg/dL
排除标准
- •Participant is participating in another clinical trial thirty days prior to enrollment.
- •Participant has a significant history or current presence of treated or untreated heart disease, kidney disease, liver disease, muscle disease, bone disease, or a history of surgery.
- •Participant has any medical condition or uses any medication, nutritional product, dietary supplement or program which might interfere with the conduct of the study or place the subject at risk.
- •Participants lost to follow-up, non-compliance, concomitant medication.
结局指标
主要结局
The changes of fasting blood glucose of the subjects
时间窗: 16 weeks
A randomized-double blind, and crossover trial values change of fasting blood glucose between before to after0, 3, 6, 10, 13 \& 16weeks
次要结局
- he changes of triglyceride of the subjects(16 weeks)
- he changes of cholesterol of the subjects(16 weeks)
研究者
You-Cheng Shen
Department of Health Diet and Industry Management
Chung Shan Medical University