Effect of Escalating Doses of a Novel Viscous Polysaccharide on Postprandial Glycemia - Full Text View

Sponsors and Collaborators:	Glycemic Index Laboratories, Inc InovoBiologic Inc. Canadian Center for Functional Medicine
Information provided by:	Glycemic Index Laboratories, Inc
ClinicalTrials.gov Identifier:	NCT00801814

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 II Phase III

MedlinePlus related topics: Dietary Supplements Flu

Drug Information available for: Dextrose

U.S. FDA Resources

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)

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
1: Placebo Comparator White Bread	Dietary Supplement: Control 0g of PGX
2: Placebo Comparator White Bread and Margarine Control	Dietary Supplement: Second Control 0g of PGX
3: Placebo Comparator Glucose drink control	Dietary Supplement: Control 0g of PGX
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
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
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
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

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:	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

Keywords provided by Glycemic Index Laboratories, Inc:

viscous
fibre
polysaccharide
blood glucose
post prandial

Study placed in the following topic categories:

Influenza, Human
Healthy

ClinicalTrials.gov processed this record on January 16, 2009