Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Fiber on Glycemic Index

NCT02615327

Healthy

COMPLETED NA

Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism

NCT07263802

Impaired Fasting Glucose (IFG) Impaired Glucose Tolerance (Prediabetes)

NOT_YET_RECRUITING NA

Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome

NCT03741686

Insulin Resistance Syndrome

COMPLETED PHASE2

Fiber Effects on Glycemic Index

NCT02831738

Healthy

COMPLETED NA

The Effect of Viscous Fiber on Glycemic Control in Individuals With Diabetes

NCT02629263

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Glucose, Postprandial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PolyGlycopleX (PGX)

2.5 grams of PGX

Intervention Type DIETARY_SUPPLEMENT

PolyGlycopleX (PGX)

5.0 grams of PGX

Intervention Type DIETARY_SUPPLEMENT

PolyGlycopleX (PGX)

0 grams of PGX

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Medications influencing gastrointestinal function
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Glycemic Index Laboratories, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexandra L Jenkins, PhD, RD

Role: STUDY_DIRECTOR

Glycemic Index Laboratories, Inc

Thomas MS Wolever, MD

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Glycemic Index Laboratories, Inc.

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 21092221 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GIL-6033

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prebiotics, Gut Microbiota, and Cardiometabolic Health

NCT02346838 COMPLETED NA

Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM

NCT03741660 COMPLETED PHASE2

Blood Glucose Response to Highly Viscous Polysaccharide Enriched Biscuits in Healthy and Diabetic Subjects

NCT00728143 COMPLETED NA

Study to Assess the Effects of Non Digestible Carbohydrates on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects

NCT04767672 ACTIVE_NOT_RECRUITING NA

Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus

NCT02204384 COMPLETED NA

Effect of Fiber Composite-enriched Breads on Glycemic Responses

NCT03224806 COMPLETED NA

Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects

NCT06789263 COMPLETED NA

Nutraceutical on Hyperglycemia

NCT04107922 COMPLETED PHASE3

Study to Evaluate the Effects of Psyllium on Blood Glucose

NCT00888602 COMPLETED NA

The Glycemic Response Elicited by Beta-glucans of Different Physical Properties and Form

NCT01610518 COMPLETED NA

Comparison of Psyllium and Microcrystalline Cellulose on Glycemic Measures in Subjects With Impaired Fasting Glucose

NCT01549600 COMPLETED NA

Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products

NCT02650674 COMPLETED NA

The Effect of NVFS on GC in Individuals With DM: SR & MA of RCTs

NCT03259724 UNKNOWN

Effect of BGG on Glucose Metabolism and Other Markers of Metabolic Syndrome

NCT02834078 COMPLETED NA

Assessment of the Glycemic Responses to Nutritional Products (v2.0)

NCT05308147 UNKNOWN NA

Konjac-Glucomannan Fibre Blend and American Ginseng in Type 2 Diabetes

NCT02806349 COMPLETED PHASE2

Prebiotics in Patients With Type 1 Diabetes

NCT04963777 RECRUITING NA

Low Glycemic Index Diet for Type 2 Diabetics

NCT01063374 COMPLETED PHASE2

Effect of a Food Supplement on Blood Glucose Levels in Patients With Impaired Glucose Values

NCT07263789 RECRUITING NA

Effects of Barley on Glucose Control

NCT02367989 ACTIVE_NOT_RECRUITING NA

OXXYNEA® GS: Study for Glycaemia Management

NCT05926947 ACTIVE_NOT_RECRUITING NA

Comparison of the Postprandial Glycemic and Insulinemic Response After a Fibersym Containing Cookie With a Control

NCT04820322 COMPLETED NA

Food Containing Resistant Starch Type 4 and Postprandial Glycemic Response

NCT03844503 COMPLETED NA

Effect of Pectin and Inulin Fibre Supplementation on Glucose and ANS Modulation

NCT06480799 COMPLETED NA

Effect of Degree of Polymerization and Linkage of α-glucans on Post-prandial Glucose Response

NCT05266690 COMPLETED NA

Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Effect of Fiber on Glycemic Index

Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism

Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome

Fiber Effects on Glycemic Index

The Effect of Viscous Fiber on Glycemic Control in Individuals With Diabetes

Detailed Description

Conditions

Study Design

Study Groups

1

PolyGlycopleX (PGX)

2

PolyGlycopleX (PGX)

3

PolyGlycopleX (PGX)

4

PolyGlycopleX (PGX)

5

PolyGlycopleX (PGX)

6

PolyGlycopleX (PGX)

7

PolyGlycopleX (PGX)

8

PolyGlycopleX (PGX)

PolyGlycopleX (PGX)

9

PolyGlycopleX (PGX)

10

PolyGlycopleX (PGX)

11

PolyGlycopleX (PGX)

12

PolyGlycopleX (PGX)

13

PolyGlycopleX (PGX)

14

PolyGlycopleX (PGX)

15

PolyGlycopleX (PGX)

Interventions

PolyGlycopleX (PGX)

PolyGlycopleX (PGX)

PolyGlycopleX (PGX)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

InovoBiologic Inc.

Canadian Center for Functional Medicine

Glycemic Index Laboratories, Inc

Responsible Party

Principal Investigators

Alexandra L Jenkins, PhD, RD

Thomas MS Wolever, MD

Locations

Glycemic Index Laboratories, Inc.

Countries

References

Other Identifiers

GIL-6033

More Related Trials