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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102452
• Other study ID #: PPB-R-203-02
• Status: Completed
• Phase: N/A
• First received: April 9, 2010
• Last updated: December 24, 2012
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2010
• Source: Pharma Power Biotec Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	PingTung Christian Hospital	Pingtung

Sponsors (1)

Lead Sponsor	Collaborator
Pharma Power Biotec Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device		2 days	No