Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

Blood Glucose, Postprandial Clinical Trial

Official title:

Effect of Adding the Novel Fiber, PGX®,to Commonly Consumed Foods on Glycemic Response and Glycemic Index: A Practical and Effective Strategy for Reducing Post Prandial Blood Glucose Levels.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935350
• Other study ID #: GIL-6033
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 25, 2009
• Last updated: July 8, 2009
• Start date: May 2006
• Est. completion date: August 2006

Study information

• Verified date: July 2009
• Source: Glycemic Index Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Reductions of postprandial glucose levels have been demonstrated previously with the addition of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods.

Description:

Recently, a commercial novel viscous polysaccharide (NVP)complex has been developed which is marketed in both the USA and Canada under the trade name PGX® (PolyGlycopleX) (InovoBiologic Inc, Calgary, AB, Canada). This complex consists of three viscous non starch polysaccharides which are processed using proprietary technology (EnviroSimplex®) to produce compressed granules which delays the onset of viscosity and increases palatability of the fiber when added to food. Previously, this fibre was shown to lower postprandial glucose levels in a dose responsive manner when mixed with a glucose drink and sprinkled onto a standard white bread demonstrating that the processing did not interfere with the effectiveness of the fiber. From this study the reduction in GI was calculated to be 7 units per gram of NVP when added to a solid food, however it is not known whether this relationship would be maintained when the NVP was added to a range of commonly eaten foods. This study therefore evaluates the effect of the addition or incorporation of NVP into a range of foods on postprandial glycemia and whether the reductions in glycemic index could be predicted using.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• healthy individuals

• 18-75 years old

• BMI less than 35 kg/m2

Exclusion Criteria:

• Medications influencing gastrointestinal function

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Glucose, Postprandial

Intervention

Dietary Supplement:
• PolyGlycopleX (PGX)
2.5 grams of PGX
• PolyGlycopleX (PGX)
5.0 grams of PGX
• PolyGlycopleX (PGX)
0 grams of PGX

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Inc.	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Glycemic Index Laboratories, Inc	Canadian Center for Functional Medicine, InovoBiologic Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Blood glucose response of food with and without NVP		Acute blood glucose response measured at 0, 15,30,45,60,90 and 120 min	No