Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

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.

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose, Postprandial
• Intervention / Treatment: Dietary supplement: PolyGlycopleX (PGX); Dietary supplement: PolyGlycopleX (PGX); Dietary supplement: PolyGlycopleX (PGX)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Glycemic Index Laboratories, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy individuals
• 18-75 years old
• BMI less than 35 kg/m2

Exclusion Criteria:

• Medications influencing gastrointestinal function
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Control White bread containing 50g available carbohydrate	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Placebo Comparator: 2; White bread and milk control	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Placebo Comparator: 3; Granola control	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Placebo Comparator: 4; Cornflakes and milk control	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Placebo Comparator: 5; White rice control	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Placebo Comparator: 6; Fruit yogurt control	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Placebo Comparator: 7; Turkey dinner control	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Experimental: 8; Granola	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Experimental: 9; Cornflakes and milk	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Experimental: 10; White Rice	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Experimental: 11; Fruit yogurt	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Experimental: 12; Turkey dinner	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Placebo Comparator: 13; White Bread	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Placebo Comparator: 14; White bread	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX
Experimental: 15; Granola	Dietary supplement: PolyGlycopleX (PGX); 2.5 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 5.0 grams of PGX; Dietary supplement: PolyGlycopleX (PGX); 0 grams of PGX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Glycemic Index Laboratories, Inc
• Collaborators: Canadian Center for Functional Medicine; InovoBiologic Inc.

Publications and helpful links

General Publications

• Jenkins AL, Kacinik V, Lyon M, Wolever TM. Effect of adding the novel fiber, PGX(R), to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial. Nutr J. 2010 Nov 22;9:58. doi: 10.1186/1475-2891-9-58.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: March 25, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 9, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2009
• Last Update Submitted That Met QC Criteria: July 8, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: postprandial; blood glucose; fibre; polysaccharide; viscous
• Other Study ID Numbers: GIL-6033