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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
Sponsor:
Collaborators:
InovoBiologic Inc.
Canadian Center for Functional Medicine
Information provided by:
Glycemic Index Laboratories, Inc

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. postprandial glycemia [ Time Frame: Acute study measuring postprandial glucose levels over 2 hours ]

Secondary Outcome Measures :
  1. The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber. [ Time Frame: Data analysis ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: December 4, 2008
Last Verified: December 2008

Keywords provided by Glycemic Index Laboratories, Inc:
viscous
fibre
polysaccharide
blood glucose
post prandial