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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 July 22, 2014