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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Dietary Supplement: PPB-R-203-Based Meal
Dietary Supplement: TK9-Based Meal

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 Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 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 continuous glucose monitoring system (CGMS) device Medtronic MiniMed. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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.

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: NCT01065402

Contacts
Contact: Hsieh Mei Huei 886-8-762-8188 judyie@isredbioresearch.com.tw

Locations
Taiwan
PingTung Christian Hospital Recruiting
Pingtung, Taiwan, 900
Contact: Chang Daw Ming, Physician    886-8-7368686 ext 2714    dawming@gmail.com   
Principal Investigator: Chuang Lee Ming, Physician         
Sponsors and Collaborators
Pharma Power Biotec Co., Ltd.
Investigators
Principal Investigator: Chuang Lee Ming, Physician National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: isRed Pharma & Biotech Research Corporation, Isredbioresearch
ClinicalTrials.gov Identifier: NCT01065402     History of Changes
Other Study ID Numbers: PPB-R-203-01
Study First Received: February 5, 2010
Last Updated: February 8, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Pharma Power Biotec Co., Ltd.:
Diabetes mellitus
continuous glucose monitoring system (CGMS)

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

ClinicalTrials.gov processed this record on October 19, 2014