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

Blood Glucose, Postprandial Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801814
• Other study ID #: GIL-5051
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 3, 2008
• Last updated: December 3, 2008
• Start date: April 2006
• Est. completion date: August 2006

Study information

• Verified date: December 2008
• Source: Glycemic Index Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• healthy individuals

• 18-75 years old

• BMI less than 35 kg/m2

Exclusion Criteria:

• Medications influencing gastrointestinal function

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Glucose, Postprandial

Intervention

Dietary Supplement:
• PolyGlycopleX (PGX)
2.5 grams of PGX
• PolyGlycopleX (PG)
5.0 grams of PGX
• PolyGlycopleX
7.5 grams of PGX
• Control
0g of PGX
• Second Control
0g of PGX

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Inc.	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Glycemic Index Laboratories, Inc	Canadian Center for Functional Medicine, InovoBiologic Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial glycemia		Acute study measuring postprandial glucose levels over 2 hours	No
Secondary	The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber.		Data analysis	No