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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