Effect of Escalating Doses of a Novel Viscous Polysaccharide on Postprandial Glycemia
This study has been completed.
Sponsor:
Glycemic Index Laboratories, Inc
Collaborators:
InovoBiologic Inc.
Canadian Center for Functional Medicine
Information provided by:
Glycemic Index Laboratories, Inc
ClinicalTrials.gov Identifier:
NCT00801814
First received: December 3, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
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Purpose
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 |
|---|---|---|
|
Blood Glucose, Postprandial |
Dietary Supplement: PolyGlycopleX (PGX) Dietary Supplement: PolyGlycopleX (PG) Dietary Supplement: PolyGlycopleX Dietary Supplement: Control Dietary Supplement: Second Control |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| 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) |
Resource links provided by NLM:
Further study details as provided by Glycemic Index Laboratories, Inc:
Primary Outcome Measures:
- postprandial glycemia [ Time Frame: Acute study measuring postprandial glucose levels over 2 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber. [ Time Frame: Data analysis ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Placebo Comparator: 1
White Bread
|
Dietary Supplement: Control
0g of PGX
|
|
Placebo Comparator: 2
White Bread and Margarine Control
|
Dietary Supplement: Second Control
0g of PGX
|
|
Placebo Comparator: 3
Glucose drink control
|
Dietary Supplement: Control
0g of PGX
|
|
Experimental: 4
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
|
|
Experimental: 5
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
|
|
Experimental: 6
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801814
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801814
Locations
| Canada, Ontario | |
| Glycemic Index Laboratories, Inc. | |
| Toronto, Ontario, Canada, M5C 2X3 | |
Sponsors and Collaborators
Glycemic Index Laboratories, Inc
InovoBiologic Inc.
Canadian Center for Functional Medicine
Investigators
| Study Director: | Alexandra L Jenkins, PhD, RD | Glycemic Index Laboratories, Inc |
| Principal Investigator: | Thomas MS Wolever, MD | Glycemic Index Laboratories, Inc |
More Information
| Responsible Party: | Dr. Alexandra Jenkins, PhD, RD/ Vice President, Glycemic Index Laboratories, Inc |
| ClinicalTrials.gov Identifier: | NCT00801814 History of Changes |
| Other Study ID Numbers: | GIL-5051 |
| Study First Received: | December 3, 2008 |
| Last Updated: | December 3, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Glycemic Index Laboratories, Inc:
|
viscous fibre polysaccharide blood glucose post prandial |
ClinicalTrials.gov processed this record on September 27, 2016