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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01102452

Enrollment

Registered

2010-04-13

Start date

2010-04-30

Completion date

2010-07-31

Last updated

2012-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

DIETARY_SUPPLEMENTCommercially 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_SUPPLEMENTPPB-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026