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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2006

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: 1
    • White Bread
  • Placebo Comparator: 2
    • White Bread and Margarine Control
  • Placebo Comparator: 3
    • Glucose drink control
  • Experimental: 4
    • White bread and margarine or Glucose drink
  • Experimental: 5
    • White bread and margarine or Glucose drink
  • Experimental: 6
    • White bread and margarine or Glucose drink

Clinical Trial Outcome Measures

Primary Measures

  • postprandial glycemia
    • Time Frame: Acute study measuring postprandial glucose levels over 2 hours

Secondary Measures

  • The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber.
    • Time Frame: Data analysis

Participating in This Clinical Trial

Inclusion Criteria

  • healthy individuals – 18-75 years old – BMI less than 35 kg/m2 Exclusion Criteria:

  • Medications influencing gastrointestinal function – Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Glycemic Index Laboratories, Inc
  • Collaborator
    • InovoBiologic Inc.
  • Provider of Information About this Clinical Study
    • Dr. Alexandra Jenkins, PhD, RD/ Vice President, Glycemic Index Laboratories, Inc
  • Overall Official(s)
    • Alexandra L Jenkins, PhD, RD, Study Director, Glycemic Index Laboratories, Inc
    • Thomas MS Wolever, MD, Principal Investigator, Glycemic Index Laboratories, Inc

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