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:

MedlinePlus related topics: Blood Sugar Flu

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

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 February 25, 2015

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