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

NCT01102452 | Completed

• 1 other identifier: PPB-R-203-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device

  2 days

Study Arms (2)

Commercially Available Wet Noodle

PLACEBO COMPARATOR

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.

Dietary Supplement: Commercially Available Wet Noodle

PPB-R-203-02 Noodle

EXPERIMENTAL

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.

Dietary Supplement: PPB-R-203-02 Noodle

Interventions

Commercially Available Wet Noodle DIETARY_SUPPLEMENT

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.

Commercially Available Wet Noodle

PPB-R-203-02 Noodle DIETARY_SUPPLEMENT

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.

PPB-R-203-02 Noodle

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pharma Power Biotec Co., Ltd.: lead

Study Sites (1)

PingTung Christian Hospital

Pingtung City, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: April 9, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 27, 2012

Record last verified: 2010-04

Locations

TW (1)