Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Oct 1996
Subchronic oral toxicity studies with erythritol in mice and rats.
Erythritol is a sugar alcohol (polyol) with potential applications as a low-calorie, bulk sweetener. Ingested erythritol is efficiently absorbed and excreted unchanged via the urine since it is not metabolized systemically by the animal or human body. Erythritol was administered to four groups of 10 male and 10 female Swiss CD-1 mice and four groups of 15 male Wistar Crl:(WI) WU BR rats at dietary levels of 0, 5, 10, or 20% for 90 days. ⋯ In conclusion, the ingestion of erythritol for 90 days at dietary levels of up to 20% did not produce signs of toxicity in mice or rats. In particular, the morphological integrity of the kidneys was not adversely affected by the treatment in either species. The increases in urinary excretion of protein, GGT, NAG, and electrolytes were considered to result from extensive osmotic diuresis and a potential overload of the renal excretory system at the high dose levels employed.
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Regul. Toxicol. Pharmacol. · Oct 1996
Plasma and urine kinetics of erythritol after oral ingestion by healthy humans.
The plasma and urine kinetics of erythritol and the effect of erythritol on plasma glucose and insulin levels were studied in human volunteers administered a single oral dose of 1 g erythritol/kg body wt. The plasma level of erythritol increased during the first 30 to 40 min, reaching a maximum value of approximately 2.2 mg/ml after 90 min. Plasma levels of erythritol then declined gradually to approximately 1.5 to 1.7 mg/ml at the end of the 3-hr sampling period. ⋯ The results of this study indicate that erythritol was readily absorbed following oral administration and was excreted unchanged in the urine. Less than 20% of erythritol remained unabsorbed and was available for colonic fermentation and potential production of short-chain fatty acids. Its caloric value was estimated to be < or = 0.4 kcal/g.
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Regul. Toxicol. Pharmacol. · Oct 1996
Effects of oral administration of erythritol on patients with diabetes.
Erythritol (20 g in solution) was administered orally in a single-dose to 5 patients with diabetes. Serum erythritol levels reached a peak 1 hr after administration and then declined rapidly. Total urinary excretion was 82.0 +/- 3.7% within 24 hr and 88.5 +/- 3.3% within 72 hr. ⋯ Indices of renal function-blood urea nitrogen, creatinine, and beta 2-microglobulin-did not change significantly. The single dose study suggests that erythritol exerts no significant effects on the metabolism of diabetic patients. Two-week daily administration of erythritol had no adverse effect on blood glucose control.
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Erythritol was orally administered to Wistar rats at dietary levels of 0, 5, and 10% for 4 weeks. Soft stools and diarrhea were observed in male and female animals of the 10% group and in female animals of the 5% group. These symptoms disappeared during the course of the study. ⋯ No treatment-related histological changes were observed. No ill effects, other than early diarrhea, were observed from erythritol levels at 5 or 10% in the diet. Based on these results, it was concluded that the feeding of erythritol at a dietary level of 10% did not result in toxicologically significant effects.