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

December 3, 2008 updated by: Glycemic Index Laboratories, Inc

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2X3
        • Glycemic Index Laboratories, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy individuals
  • 18-75 years old
  • BMI less than 35 kg/m2

Exclusion Criteria:

  • Medications influencing gastrointestinal function
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postprandial glycemia
Time Frame: Acute study measuring postprandial glucose levels over 2 hours
Acute study measuring postprandial glucose levels over 2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glycemic Index Laboratories, Inc

Collaborators

Canadian Center for Functional Medicine
InovoBiologic Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

August 1, 2006

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (ESTIMATE)

December 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2008

Last Update Submitted That Met QC Criteria

December 3, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GIL-5051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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