The safety of PolyGlycopleX® (PGX®) as shown in a 90-day rodent feeding study
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1 Burdock Group, 801 North Orange Avenue, Suite 710, Orlando, FL 32801 USA
2 Canadian Centre for Functional Medicine, 1552 United Boulevard, Coquitlam, BC, V3K 6Y2, Canada
3 University of British Columbia, Food, Nutrition and Health Program, 2357 Main Mall, Vancouver, B.C., V6T 1Z4, Canada
4 Eurofins|Product Safety Laboratories, 2394 Highway 130, Dayton, NJ 08810 USA
Nutrition Journal 2009, 8:1 doi:10.1186/1475-2891-8-1Published: 16 January 2009
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.
Groups 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.
Mean 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.
The 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.