A Randomized, Two-Regimen, Crossover, Comparative Study to Evaluate the Blood Glucose Regulation and Safety of PPB-R-203-02 Based Noodle Versus Commercially Available Wet Noodle in 24 Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device
研究概览
简要总结
To evaluate the result of PPB-R-203-02 based noodle and commercially available wet noodle on blood glucose control in 24 patients with diabetes for 2 days.
详细描述
The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus patient.
- •Aged between 20 to 65 years old.
- •Informed consent form signed.
排除标准
- •A recent history of drug or alcohol abuse.
- •Sensitivity to analogous product.
- •Serious cardiovascular disorders.
- •Participation in another clinical investigation study.
- •Ongoing influenza, autoimmune disease and other metabolic diseases.
- •Pregnant or lactating women.
- •Individuals are judged by the investigators or co-investigator to be undesirable as subjects.
研究组 & 干预措施
Commercially Available Wet Noodle
Commercially Available Wet Noodle will be served as a diet equivalent to daily energy needs as judged by indirect calorimetry and of same macronutrient composition.
干预措施: Commercially Available Wet Noodle (Dietary Supplement)
PPB-R-203-02 Noodle
PPB-R-203-02 Noodle is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203-02 Noodle is resistant starch (RS). By definition, resistant starch (RS) is any starch that is not digested in the small intestine but passes to the large intestine (or the colon). Therefore, resistant starch can be regarded as a component of dietary fiber. PPB-R-203-02 Noodle will be served as a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
干预措施: PPB-R-203-02 Noodle (Dietary Supplement)
结局指标
主要结局
The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device
时间窗: 2 days
次要结局
未报告次要终点