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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Blood Glucose, Postprandial

Intervention / Treatment
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* Dietary Supplement: PolyGlycopleX (PGX)
* Dietary Supplement: PolyGlycopleX (PG)
* Dietary Supplement: PolyGlycopleX
* Dietary Supplement: Control
* Dietary Supplement: Second Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy individuals 18-75 years old BMI less than 35 kg/m2 Exclusion Criteria: Medications influencing gastrointestinal function Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>White Bread | Dietary Supplement: Control<br>* 0g of PGX<br>|
| Placebo Comparator: 2<br>White Bread and Margarine Control | Dietary Supplement: Second Control<br>* 0g of PGX<br>|
| Placebo Comparator: 3<br>Glucose drink control | Dietary Supplement: Control<br>* 0g of PGX<br>|
| Experimental: 4<br>White bread and margarine or Glucose drink | Dietary Supplement: PolyGlycopleX (PGX)<br>* 2.5 grams of PGX<br>Dietary Supplement: PolyGlycopleX (PG)<br>* 5.0 grams of PGX<br>Dietary Supplement: PolyGlycopleX<br>* 7.5 grams of PGX<br>|
| Experimental: 5<br>White bread and margarine or Glucose drink | Dietary Supplement: PolyGlycopleX (PGX)<br>* 2.5 grams of PGX<br>Dietary Supplement: PolyGlycopleX (PG)<br>* 5.0 grams of PGX<br>Dietary Supplement: PolyGlycopleX<br>* 7.5 grams of PGX<br>|
| Experimental: 6<br>White bread and margarine or Glucose drink | Dietary Supplement: PolyGlycopleX (PGX)<br>* 2.5 grams of PGX<br>Dietary Supplement: PolyGlycopleX (PG)<br>* 5.0 grams of PGX<br>Dietary Supplement: PolyGlycopleX<br>* 7.5 grams of PGX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial glycemia |  | Acute study measuring postprandial glucose levels over 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber. |  | Data analysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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viscous, fibre, polysaccharide, blood glucose, post prandial