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

December 24, 2012 updated by: Pharma Power Biotec Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Pingtung, Taiwan
        • Pingtung Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharma Power Biotec Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

December 27, 2012

Last Update Submitted That Met QC Criteria

December 24, 2012

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPB-R-203-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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