The safety of PolyGlycopleX (PGX) as shown in a 90-day rodent feeding study.

Ray A Matulka,Daniel J Merkel,George A Burdock,Michael R Lyon,Simon Wood,Palma Ann Marone

doi:10.1186/1475-2891-8-1

Abstract

BackgroundThis study was designed to evaluate the safety of PolyGlycopleX® (PGX®), a novel viscous dietary polysaccharide (fiber), when administered to Sprague Dawley® rats in the diet for 90 days.MethodsGroups of ten male and ten female rats each consumed PGX mixed in the diet at levels of 0, 1.25, 2.5 or 5.0% for 90 days, then evaluated for toxicological effects on parameters that included neuromotor activity, body weight, clinical chemistry, urinalysis, hematology, and histopathology.ResultsMean body weight, mean feed consumption and food efficiency in the treated groups were generally comparable to controls for both male and female rats. No changes were noted in neuromotor behavior, and histopathological analysis revealed no significant changes between treated and control animals. There were no differences in mean organ weight, organ-to-body weight or organ-to-brain weight values between controls and treated animals. Decreased red blood cell count occurred in the high dose males and increases in aspartate and alanine aminotransferase enzyme levels and triglycerides, while significant decreases in serum sodium, potassium and chloride concentrations were observed in the females fed 5.0% PGX. However, the decreased mineral concentrations may be the result of significantly increased urinary volume in both males and females at the high dose, with a concomitant decrease in urinary specific gravity (males and females) and protein concentration (females). These results were within historical control values, did not correlate with any histopathological changes, and were not considered adverse.ConclusionThe results indicate a no observed adverse effect level (NOAEL) for PGX at 5.0% of the diet, corresponding to an average daily intake of 3219 and 3799 mg/kg bw/day in male and female rats, respectively.

Highlights

This study was designed to evaluate the safety of PolyGlycopleX® (PGX®), a novel viscous dietary polysaccharide, when administered to Sprague Dawley® rats in the diet for 90 days
Many positive benefits have been associated with diets rich in fiber, including a reduced risk of diabetes and cardiovascular disease, reduced risk of hypertension, as well as a reduction of total and low density lipoprotein (LDL) cholesterol [2] and an increase in high density lipoprotein (HDL) cholesterol [3,4,5,6]
Mean daily food consumption and food efficiency for all groups of male and female rats that consumed 1.25, 2.5, or 5.0% PGX were comparable with control values (Figure 1)

Summary

Introduction

This study was designed to evaluate the safety of PolyGlycopleX® (PGX®), a novel viscous dietary polysaccharide (fiber), when administered to Sprague Dawley® rats in the diet for 90 days. The Institute of Medicine [1] states that "Dietary fiber consists of nondigestible food plant carbohydrates and lignin in which the plant matrix is largely intact. Nondigestible means that the material is not digested and absorbed in the human small intestine." Dietary fibers are defined as either soluble or insoluble (depending on solubility characteristics), and fermentable or non-fermentable, depending on the ability of anaerobic bacteria in the colon to digest the fiber. This definition encompasses a broad category of carbohydrates, including cellulosic plant material, pectins, gums, and non-plant (e.g., animal or fungal) dietary substances. The type of fiber may affect food consumption, as some fibers have the ability to swell and hold water, inducing a feeling of fullness [7], which can aid in the maintenance of, or a reduction in, body weight

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