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A Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Pharma Power Biotec Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Pharma Power Biotec Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01065402
First received: February 5, 2010
Last updated: February 8, 2010
Last verified: February 2010

February 5, 2010
February 8, 2010
February 2010
March 2010   (final data collection date for primary outcome measure)
The daily blood glucose level will be monitored by the continuous glucose monitoring system (CGMS) device Medtronic MiniMed. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065402 on ClinicalTrials.gov Archive Site
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A Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes
A Randomized, Two-Regimen, Crossover, Comparative Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes

To evaluate the efficacy of PPB-R-203-Based Meal and TK9-Based Meal on blood glucose control in 20 patients with diabetes for 2 days.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Diabetes Mellitus
  • Dietary Supplement: PPB-R-203-Based Meal
    PPB-R-203 is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203 is resistant starch (RS). Resistant starch can be regarded as a component of dietary fiber. Some forms of RS are present naturally in many foods, and average global consumption is estimated at 3-10 g/day. PPB-R-203-Based is the diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
  • Dietary Supplement: TK9-Based Meal
    TK9, Taikeng 9, is one commercially available rice manufacture by Yeedon Enterprise Co., Ltd. TK9-Based Meal is a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
  • Placebo Comparator: TK9-Based Meal
    TK9, Taikeng 9, is one commercially available rice manufacture by Yeedon Enterprise Co., Ltd. TK9-Based Meal is a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
    Intervention: Dietary Supplement: TK9-Based Meal
  • Experimental: PPB-R-203-Based Meal

    PPB-R-203 is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203 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. RS intake is associated with several changes in metabolism which may confer some health benefits.

    PPB-R-203-Based is the diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.

    Intervention: Dietary Supplement: PPB-R-203-Based Meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
No
Contact: Hsieh Mei Huei 886-8-762-8188 judyie@isredbioresearch.com.tw
Taiwan
 
NCT01065402
PPB-R-203-01
Not Provided
isRed Pharma & Biotech Research Corporation, Isredbioresearch
Pharma Power Biotec Co., Ltd.
Not Provided
Principal Investigator: Chuang Lee Ming, Physician National Taiwan University Hospital
Pharma Power Biotec Co., Ltd.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP