Research

Supplementation of the diet with the functional fiber PolyGlycoplex^® is well tolerated by healthy subjects in a clinical trial

Ioana G Carabin¹ , Michael R Lyon^2,3 , Simon Wood² , Xavier Pelletier⁴ , Yves Donazzolo⁴ and George A Burdock¹

¹  Burdock Group, Orlando, Florida, USA

²  Canadian Centre for Functional Medicine, Coquitlam, British Columbia, Canada

³  Food, Nutrition and Health Program, University of British Columbia, Coquitlam, British Columbia, Canada

⁴  OPTIMED Clinical Research, Gieres, France

author email corresponding author email

Nutrition Journal 2009, 8:9doi:10.1186/1475-2891-8-9

Published:	5 February 2009

Abstract

Background

The relationship of dietary fiber to overall health is of great importance, as beneficial effects have been demonstrated with the use of fiber from diverse sources, some traditional, other novel. PolyGlycopleX^® (PGX^®) is a unique proprietary product composed of three water-soluble polysaccharides, that when processed using novel technology give rise to a final product – a soluble, highly viscous functional fiber.

Methods

Because of its potential use in food and dietary supplements, a randomized, double-blind, placebo controlled clinical study was conducted to evaluate the tolerance to PGX ingestion for 21 days, to a maximum dose level of 10 g per day, in healthy male and female volunteers. The main objective of the study was to evaluate the overall gastrointestinal (GI) tolerance, while secondary objectives were to evaluate possible changes in hematological, biochemical, urinary and fecal parameters.

Results

Results show that PGX is well tolerated as part of a regular diet with only mild to moderate adverse effects, similar to those seen with a moderate intake of dietary fiber in general, and fruits and vegetables. Because PGX is a highly viscous, functional fiber, it also demonstrates several physiological responses including, but not limited to maintaining healthy total and LDL cholesterol and uric acid levels.