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Effect of Escalating Doses of a Novel Viscous Polysaccharide on Postprandial Glycemia

This study has been completed.
Sponsor:
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
  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:

U.S. FDA Resources

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
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

No publications provided

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 May 19, 2013