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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: Commercially Available Wet Noodle; Dietary Supplement: PPB-R-203-02 Noodle

• Registration Number: NCT01102452
• Lead Sponsor: Pharma Power Biotec Co., Ltd.

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2012-12-24
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Commercially Available Wet Noodle	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.
PPB-R-203-02 Noodle	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

PingTung Christian Hospital; 🇨🇳 Pingtung, Taiwan