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Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935350
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : July 9, 2009
Sponsor:
Collaborators:
InovoBiologic Inc.
Canadian Center for Functional Medicine
Information provided by:
Glycemic Index Laboratories, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Blood Glucose, Postprandial Dietary Supplement: PolyGlycopleX (PGX) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : May 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Placebo Comparator: 1
Control White bread containing 50g available carbohydrate
Dietary Supplement: PolyGlycopleX (PGX)
0 grams of PGX

Placebo Comparator: 2
White bread and milk control
Dietary Supplement: PolyGlycopleX (PGX)
0 grams of PGX

Placebo Comparator: 3
Granola control
Dietary Supplement: PolyGlycopleX (PGX)
0 grams of PGX

Placebo Comparator: 4
Cornflakes and milk control
Dietary Supplement: PolyGlycopleX (PGX)
0 grams of PGX

Placebo Comparator: 5
White rice control
Dietary Supplement: PolyGlycopleX (PGX)
0 grams of PGX

Placebo Comparator: 6
Fruit yogurt control
Dietary Supplement: PolyGlycopleX (PGX)
0 grams of PGX

Placebo Comparator: 7
Turkey dinner control
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

Experimental: 9
Cornflakes and milk
Dietary Supplement: PolyGlycopleX (PGX)
5.0 grams of PGX

Experimental: 10
White Rice
Dietary Supplement: PolyGlycopleX (PGX)
5.0 grams of PGX

Experimental: 11
Fruit yogurt
Dietary Supplement: PolyGlycopleX (PGX)
5.0 grams of PGX

Experimental: 12
Turkey dinner
Dietary Supplement: PolyGlycopleX (PGX)
5.0 grams of PGX

Placebo Comparator: 13
White Bread
Dietary Supplement: PolyGlycopleX (PGX)
0 grams of PGX

Placebo Comparator: 14
White bread
Dietary Supplement: PolyGlycopleX (PGX)
0 grams of PGX

Experimental: 15
Granola
Dietary Supplement: PolyGlycopleX (PGX)
2.5 grams of PGX




Primary Outcome Measures :
  1. Relative Blood glucose response of food with and without NVP [ Time Frame: Acute blood glucose response measured at 0, 15,30,45,60,90 and 120 min ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Medications influencing gastrointestinal function
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935350


Locations
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Canada, Ontario
Glycemic Index Laboratories, Inc.
Toronto, Ontario, Canada
Sponsors and Collaborators
Glycemic Index Laboratories, Inc
InovoBiologic Inc.
Canadian Center for Functional Medicine
Investigators
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Study Director: Alexandra L Jenkins, PhD, RD Glycemic Index Laboratories, Inc
Principal Investigator: Thomas MS Wolever, MD Glycemic Index Laboratories, Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Alexandra Jenkins, PhD, RD/ Vice President, Glycemic Index Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00935350    
Other Study ID Numbers: GIL-6033
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009
Keywords provided by Glycemic Index Laboratories, Inc:
viscous
fibre
polysaccharide
blood glucose
postprandial