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

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: TK9-Based Meal; Dietary Supplement: PPB-R-203-Based Meal

• Registration Number: NCT01065402
• Lead Sponsor: Pharma Power Biotec Co., Ltd.

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2010-02
• Study Start: 2010-02
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-08
• Last Update Submitted: 2010-02-08
• Study First Posted: 2010-02-09
• Last Update Posted: 2010-02-09
• Primary Completion: 2010-03
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TK9-Based Meal	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.
PPB-R-203-Based Meal	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.

Primary Outcome Measures

Name	Time	Method
The daily blood glucose level will be monitored by the continuous glucose monitoring system (CGMS) device Medtronic MiniMed.	2 days

Trial Locations

Locations (1)

PingTung Christian Hospital; 🇨🇳 Pingtung, Taiwan