A Study to Evaluate the Blood Glucose Regulation and Safety of PPB-R-203-02 Based Noodle Versus Commercially Available Wet Noodle in Patients With Diabetes

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2010

Detailed Description

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.

Interventions

  • Dietary Supplement: 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.
  • 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.

Arms, Groups and Cohorts

  • Placebo Comparator: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device
    • Time Frame: 2 days

Participating in This Clinical Trial

Inclusion Criteria

1. Diabetes mellitus patient. 2. Aged between 20 to 65 years old. 3. Informed consent form signed. Exclusion Criteria:

1. A recent history of drug or alcohol abuse. 2. Sensitivity to analogous product. 3. Serious cardiovascular disorders. 4. Participation in another clinical investigation study. 5. Ongoing influenza, autoimmune disease and other metabolic diseases. 6. Pregnant or lactating women. 7. Individuals are judged by the investigators or co-investigator to be undesirable as subjects.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pharma Power Biotec Co., Ltd.
  • Provider of Information About this Clinical Study
    • isRed Pharma & Biotech Research Corporation, Isredbioresearch

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