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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Feb 2010
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 5, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 9, 2010
February 1, 2010
28 days
February 5, 2010
February 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The daily blood glucose level will be monitored by the continuous glucose monitoring system (CGMS) device Medtronic MiniMed.
2 days
Study Arms (2)
TK9-Based Meal
PLACEBO COMPARATORTK9, 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
EXPERIMENTALPPB-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diabetes mellitus patient.
- Aged between 20 to 65 years old.
- Informed consent form signed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PingTung Christian Hospital
Pingtung City, 900, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chuang Lee Ming, Physician
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 5, 2010
First Posted
February 9, 2010
Study Start
February 1, 2010
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
February 9, 2010
Record last verified: 2010-02