CClinicalTrials.gg
CompletedNCT00935350Updated Jul 9, 2009

Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

A Phase 2/3 interventional study of PolyGlycopleX (PGX) and PolyGlycopleX (PGX) in Blood Glucose, Postprandial, sponsored by Glycemic Index Laboratories, Inc. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-09.

Sponsored by Glycemic Index Laboratories, Inc · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Reductions of postprandial glucose levels have been demonstrated previously with the addition of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods.

Read the detailed description

Recently, a commercial novel viscous polysaccharide (NVP)complex has been developed which is marketed in both the USA and Canada under the trade name PGX® (PolyGlycopleX) (InovoBiologic Inc, Calgary, AB, Canada). This complex consists of three viscous non starch polysaccharides which are processed using proprietary technology (EnviroSimplex®) to produce compressed granules which delays the onset of viscosity and increases palatability of the fiber when added to food. Previously, this fibre was shown to lower postprandial glucose levels in a dose responsive manner when mixed with a glucose drink and sprinkled onto a standard white bread demonstrating that the processing did not interfere with the effectiveness of the fiber. From this study the reduction in GI was calculated to be 7 units per gram of NVP when added to a solid food, however it is not known whether this relationship would be maintained when the NVP was added to a range of commonly eaten foods. This study therefore evaluates the effect of the addition or incorporation of NVP into a range of foods on postprandial glycemia and whether the reductions in glycemic index could be predicted using.

02

Conditions studied

  • Blood Glucose, Postprandial

Keywords

  • viscous
  • fibre
  • polysaccharide
  • blood glucose
  • postprandial
03

In context

Lead sponsor

Glycemic Index Laboratories, Inc is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Medications influencing gastrointestinal function
  • Pregnancy
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Placebo comparator
    1

    Control White bread containing 50g available carbohydrate

    Dietary Supplement: PolyGlycopleX (PGX)

  • Placebo comparator
    2

    White bread and milk control

    Dietary Supplement: PolyGlycopleX (PGX)

  • Placebo comparator
    3

    Granola control

    Dietary Supplement: PolyGlycopleX (PGX)

  • Placebo comparator
    4

    Cornflakes and milk control

    Dietary Supplement: PolyGlycopleX (PGX)

  • Placebo comparator
    5

    White rice control

    Dietary Supplement: PolyGlycopleX (PGX)

  • Placebo comparator
    6

    Fruit yogurt control

    Dietary Supplement: PolyGlycopleX (PGX)

  • Placebo comparator
    7

    Turkey dinner control

    Dietary Supplement: PolyGlycopleX (PGX)

  • Experimental
    8

    Granola

    Dietary Supplement: PolyGlycopleX (PGX)

  • Experimental
    9

    Cornflakes and milk

    Dietary Supplement: PolyGlycopleX (PGX)

  • Experimental
    10

    White Rice

    Dietary Supplement: PolyGlycopleX (PGX)

  • Experimental
    11

    Fruit yogurt

    Dietary Supplement: PolyGlycopleX (PGX)

  • Experimental
    12

    Turkey dinner

    Dietary Supplement: PolyGlycopleX (PGX)

  • Placebo comparator
    13

    White Bread

    Dietary Supplement: PolyGlycopleX (PGX)

  • Placebo comparator
    14

    White bread

    Dietary Supplement: PolyGlycopleX (PGX)

  • Experimental
    15

    Granola

    Dietary Supplement: PolyGlycopleX (PGX)

Interventions

  • Dietary supplementPolyGlycopleX (PGX)

    2.5 grams of PGX

  • Dietary supplementPolyGlycopleX (PGX)

    5.0 grams of PGX

  • Dietary supplementPolyGlycopleX (PGX)

    0 grams of PGX

06

What researchers measure

Primary outcomes

  1. Relative Blood glucose response of food with and without NVP

    Time frame: Acute blood glucose response measured at 0, 15,30,45,60,90 and 120 min

07

Study locations

1 site
  • Glycemic Index Laboratories, Inc.
    Toronto, Ontario, Canada
08

References and documents

Publications

  • Jenkins AL, Kacinik V, Lyon M, Wolever TM. Effect of adding the novel fiber, PGX(R), to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial. Nutr J. 2010 Nov 22;9:58. doi: 10.1186/1475-2891-9-58. PubMed 21092221 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00935350
Lead sponsor
Glycemic Index Laboratories, Inc
Collaborators
InovoBiologic Inc., Canadian Center for Functional Medicine
First posted
Jul 9, 2009
Start date
May 2006
Primary completion
Jun 2006
Completion
Aug 2006
Last update
Jul 9, 2009

Study contacts

Alexandra L Jenkins, PhD, RD
study director · Glycemic Index Laboratories, Inc
Thomas MS Wolever, MD
principal investigator · Glycemic Index Laboratories, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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