Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Blood Glucose, Postprandial

Intervention / Treatment
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* Dietary Supplement: PolyGlycopleX (PGX)
* Dietary Supplement: PolyGlycopleX (PGX)
* Dietary Supplement: PolyGlycopleX (PGX)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy individuals 18-75 years old BMI less than 35 kg/m2 Exclusion Criteria: Medications influencing gastrointestinal function Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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viscous, fibre, polysaccharide, blood glucose, postprandial