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Sponsors and Collaborators: |
Glycemic Index Laboratories, Inc InovoBiologic Inc. Canadian Center for Functional Medicine |
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Information provided by: | Glycemic Index Laboratories, Inc |
ClinicalTrials.gov Identifier: | NCT00801814 |
To determine palatability and extent to which escalating doses of a novel highly viscous polysaccharide [NVP] reduces postprandial glycemia when added to a liquid and a solid meal.
Condition | Intervention | Phase |
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Blood Glucose, Postprandial |
Dietary Supplement: PolyGlycopleX (PGX) Dietary Supplement: PolyGlycopleX (PG) Dietary Supplement: PolyGlycopleX Dietary Supplement: Control Dietary Supplement: Second Control |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effect of Adding Escalating Doses of a Novel Highly Viscous Polysaccharide to Either a Liquid or a Solid Test Meal on Post Prandial Glycemia in Healthy Subjects: Determination of the Glycemic Reduction Index Potential (GRIP) |
Enrollment: | 20 |
Study Start Date: | April 2006 |
Study Completion Date: | August 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
White Bread
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Dietary Supplement: Control
0g of PGX
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2: Placebo Comparator
White Bread and Margarine Control
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Dietary Supplement: Second Control
0g of PGX
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3: Placebo Comparator
Glucose drink control
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Dietary Supplement: Control
0g of PGX
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4: Experimental
White bread and margarine or Glucose drink |
Dietary Supplement: PolyGlycopleX (PGX)
2.5 grams of PGX
Dietary Supplement: PolyGlycopleX (PG)
5.0 grams of PGX
Dietary Supplement: PolyGlycopleX
7.5 grams of PGX
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5: Experimental
White bread and margarine or Glucose drink |
Dietary Supplement: PolyGlycopleX (PGX)
2.5 grams of PGX
Dietary Supplement: PolyGlycopleX (PG)
5.0 grams of PGX
Dietary Supplement: PolyGlycopleX
7.5 grams of PGX
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6: Experimental
White bread and margarine or Glucose drink |
Dietary Supplement: PolyGlycopleX (PGX)
2.5 grams of PGX
Dietary Supplement: PolyGlycopleX (PG)
5.0 grams of PGX
Dietary Supplement: PolyGlycopleX
7.5 grams of PGX
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Glycemic Index Laboratories, Inc. | |
Toronto, Ontario, Canada, M5C 2X3 |
Study Director: | Alexandra L Jenkins, PhD, RD | Glycemic Index Laboratories, Inc |
Principal Investigator: | Thomas MS Wolever, MD | Glycemic Index Laboratories, Inc |
Responsible Party: | Glycemic Index Laboratories, Inc ( Dr. Alexandra Jenkins, PhD, RD/ Vice President ) |
Study ID Numbers: | GIL-5051 |
Study First Received: | December 3, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00801814 |
Health Authority: | Canada: Health Canada |
viscous fibre polysaccharide blood glucose post prandial |
Influenza, Human Healthy |