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
Recruitment status was Recruiting
Sponsor:
Pharma Power Biotec Co., Ltd.
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
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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.
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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:
- 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.
Contacts and Locations
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 May 19, 2013