Effect of Escalating Doses of a Novel Viscous Polysaccharide on Postprandial Glycemia
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ClinicalTrials.gov Identifier: NCT00801814 |
Recruitment Status :
Completed
First Posted : December 4, 2008
Last Update Posted : December 4, 2008
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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) |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | May 2006 |
Actual Study Completion Date : | August 2006 |
Arm | Intervention/treatment |
---|---|
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 |
- postprandial glycemia [ Time Frame: Acute study measuring postprandial glucose levels over 2 hours ]
- The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber. [ Time Frame: Data analysis ]

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

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): NCT00801814
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: | Dr. Alexandra Jenkins, PhD, RD/ Vice President, Glycemic Index Laboratories, Inc |
ClinicalTrials.gov Identifier: | NCT00801814 |
Other Study ID Numbers: |
GIL-5051 |
First Posted: | December 4, 2008 Key Record Dates |
Last Update Posted: | December 4, 2008 |
Last Verified: | December 2008 |
viscous fibre polysaccharide blood glucose post prandial |