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NCT Number: NCT01102452

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PingTung Christian Hospital

Pingtung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes mellitus patient.
  • Aged between 20 to 65 years old.
  • Informed consent form signed.

Exclusion criteria

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

Treatment and study plan

Commercially Available Wet Noodle

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Pharma Power Biotec Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2010
Registry last updated
Dec 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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