Home
Clinical Trials
NCT00801814

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

NCT ID: NCT00801814

Last Updated: 2008-12-04

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

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.

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.

Detailed Description

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

Conditions

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

Blood Glucose, Postprandial

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

viscous fibre polysaccharide blood glucose post prandial

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

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

White Bread

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

0g of PGX

2

White Bread and Margarine Control

Group Type PLACEBO_COMPARATOR

Second Control

Intervention Type DIETARY_SUPPLEMENT

0g of PGX

3

Glucose drink control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

0g of PGX

4

White bread and margarine

or

Glucose drink

Group Type EXPERIMENTAL

PolyGlycopleX (PGX)

Intervention Type DIETARY_SUPPLEMENT

2.5 grams of PGX

PolyGlycopleX (PG)

Intervention Type DIETARY_SUPPLEMENT

5.0 grams of PGX

PolyGlycopleX

Intervention Type DIETARY_SUPPLEMENT

7.5 grams of PGX

5

White bread and margarine

or

Glucose drink

Group Type EXPERIMENTAL

PolyGlycopleX (PGX)

Intervention Type DIETARY_SUPPLEMENT

2.5 grams of PGX

PolyGlycopleX (PG)

Intervention Type DIETARY_SUPPLEMENT

5.0 grams of PGX

PolyGlycopleX

Intervention Type DIETARY_SUPPLEMENT

7.5 grams of PGX

6

White bread and margarine

or

Glucose drink

Group Type EXPERIMENTAL

PolyGlycopleX (PGX)

Intervention Type DIETARY_SUPPLEMENT

2.5 grams of PGX

PolyGlycopleX (PG)

Intervention Type DIETARY_SUPPLEMENT

5.0 grams of PGX

PolyGlycopleX

Intervention Type DIETARY_SUPPLEMENT

7.5 grams of PGX

Interventions

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 (PG)

5.0 grams of PGX

Intervention Type DIETARY_SUPPLEMENT

PolyGlycopleX

7.5 grams of PGX

Intervention Type DIETARY_SUPPLEMENT

Control

0g of PGX

Intervention Type DIETARY_SUPPLEMENT

Second Control

0g 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

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

InovoBiologic Inc.

INDUSTRY

Sponsor Role collaborator

Canadian Center for Functional Medicine

OTHER

Sponsor Role collaborator

Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role lead

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

Other Identifiers

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

GIL-5051

Identifier Type: -

Identifier Source: org_study_id