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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01102452
First Posted: April 13, 2010
Last Update Posted: December 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharma Power Biotec Co., Ltd.
  Purpose
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.

Condition Intervention
Diabetes Mellitus Dietary Supplement: Commercially Available Wet Noodle Dietary Supplement: PPB-R-203-02 Noodle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Pharma Power Biotec Co., Ltd.:

Primary Outcome Measures:
  • The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device [ Time Frame: 2 days ]

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102452


Locations
Taiwan
PingTung Christian Hospital
Pingtung, Taiwan
Sponsors and Collaborators
Pharma Power Biotec Co., Ltd.
  More Information

Responsible Party: isRed Pharma & Biotech Research Corporation, Isredbioresearch
ClinicalTrials.gov Identifier: NCT01102452     History of Changes
Other Study ID Numbers: PPB-R-203-02
First Submitted: April 9, 2010
First Posted: April 13, 2010
Last Update Posted: December 27, 2012
Last Verified: April 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases