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Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

G

Glycemic Index Laboratories

Status and phase

Completed
Phase 3
Phase 2

Conditions

Blood Glucose, Postprandial

Treatments

Dietary Supplement: PolyGlycopleX (PGX)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00935350
GIL-6033

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Medications influencing gastrointestinal function
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 15 patient groups, including a placebo group

1
Placebo Comparator group
Description:
Control White bread containing 50g available carbohydrate
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
2
Placebo Comparator group
Description:
White bread and milk control
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
3
Placebo Comparator group
Description:
Granola control
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
4
Placebo Comparator group
Description:
Cornflakes and milk control
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
5
Placebo Comparator group
Description:
White rice control
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
6
Placebo Comparator group
Description:
Fruit yogurt control
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
7
Placebo Comparator group
Description:
Turkey dinner control
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
8
Experimental group
Description:
Granola
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
9
Experimental group
Description:
Cornflakes and milk
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
10
Experimental group
Description:
White Rice
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
11
Experimental group
Description:
Fruit yogurt
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
12
Experimental group
Description:
Turkey dinner
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
13
Placebo Comparator group
Description:
White Bread
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
14
Placebo Comparator group
Description:
White bread
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
15
Experimental group
Description:
Granola
Treatment:
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: PolyGlycopleX (PGX)

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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