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:
Information provided by:
Pharma Power Biotec Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01102452
First received: April 9, 2010
Last updated: December 24, 2012
Last verified: April 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102452

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

No publications provided

Responsible Party: isRed Pharma & Biotech Research Corporation, Isredbioresearch
ClinicalTrials.gov Identifier: NCT01102452     History of Changes
Other Study ID Numbers: PPB-R-203-02
Study First Received: April 9, 2010
Last Updated: December 24, 2012
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on October 22, 2014