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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01065402

Enrollment

Registered

2010-02-09

Start date

2010-02-28

Completion date

2010-04-30

Last updated

2010-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus, continuous glucose monitoring system (CGMS)

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.

Interventions

DIETARY_SUPPLEMENTPPB-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_SUPPLEMENTTK9-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Taiwan

Contacts

Primary ContactHsieh Mei Huei

judyie@isredbioresearch.com.tw886-8-762-8188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026