A Study to Evaluate the Blood Glucose Regulation and Safety of PPB-R-203-02 Based Noodle Versus Commercially Available Wet Noodle in Patients With Diabetes

Pharma Power Biotec

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Dietary Supplement: Commercially Available Wet Noodle; Dietary Supplement: PPB-R-203-02 Noodle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01102452

PPB-R-203-02

Details and patient eligibility

About

To evaluate the result of PPB-R-203-02 based noodle and commercially available wet noodle on blood glucose control in 24 patients with diabetes for 2 days.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

Commercially Available Wet Noodle

Placebo Comparator group

Description:

Commercially Available Wet Noodle will be served as a diet equivalent to daily energy needs as judged by indirect calorimetry and of same macronutrient composition.

Treatment:

Dietary Supplement: Commercially Available Wet Noodle

PPB-R-203-02 Noodle

Experimental group

Description:

PPB-R-203-02 Noodle is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203-02 Noodle 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. PPB-R-203-02 Noodle will be served as a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.

Treatment:

Dietary Supplement: PPB-R-203-02 Noodle