Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Oct 1996
Chronic toxicity and carcinogenicity study of erythritol in rats.
The potential toxicity and carcinogenicity of erythritol, a low-calorie sugar substitute, were examined in Wistar Crl:(WI) WU BR rats. Groups of 50 rats of each sex consumed diets with 0, 2, 5, or 10% erythritol, or 10% mannitol, for a period of 104-107 weeks. To each of these main groups, two satellite groups of 20 males each were attached for interim kills after 52 and 78 weeks of treatment. ⋯ In conclusion, the toxicological profile of erythritol in rats resembles that of other polyols in several respects. Except for nephrocalcinosis, which is commonly seen in polyol-fed rats, no other treatment-related, morphological changes were observed in the kidneys. Evidence for a tumor-inducing or tumor-promoting effect of erythritol was not seen.
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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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The chronic oral toxicity of erythritol was examined by feeding erythritol at dietary levels of 0 (controls), 2, 5, or 10% to groups of four male and four female dogs for 53 weeks. Erythritol was well tolerated at all dose levels without evidence of diarrhea. Water consumption was slightly higher in the high-dose group than in controls. ⋯ Analysis of terminal organ weights did not reveal treatment-related differences. No histopathological changes attributable to treatment were observed in the kidneys or in any other organ or tissue examined. It was concluded that daily erythritol consumption of up to 3.5 g/kg body wt was well tolerated by dogs.
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Regul. Toxicol. Pharmacol. · Oct 1996
Clinical Trial Controlled Clinical TrialTolerance to subchronic, high-dose ingestion of erythritol in human volunteers.
Erythritol is a sugar alcohol (polyol) which is absorbed from the small intestine in substantial amounts, not metabolized in the human body, and therefore excreted in the urine. Erythritol holds promise as a low-calorie sugar substitute. Human tolerance to repeated oral doses of erythritol was examined in a double-blind, two-way crossover study in 12 healthy, male volunteers. ⋯ The urinary excretions of albumin, beta 2-microglobulin, and N-acetyl-glucosaminidase were slightly elevated during the erythritol test period but they were still well within the physiological range. None of the observed urinary changes became more pronounced with increasing duration of the erythritol treatment. In conclusion, the results of the present study demonstrate that the repeated ingestion of erythritol at daily doses of 1 g/kg body wt was well tolerated by humans.
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Regul. Toxicol. Pharmacol. · Oct 1996
Disposition of 14C-erythritol in germfree and conventional rats.
The metabolism and disposition of U-14C-erythritol was examined in four groups of three male and three female, nonfasted rats each. The rats of groups A and D were germfree; the rats of groups B and C were kept under conventional conditions. The rats of group B received an erythritol-supplemented diet for 3 weeks prior to the experiment (adapted rats). ⋯ It is concluded that ingested erythritol is efficiently absorbed mainly from the small intestine, is not metabolized to a relevant extent in the body, and is excreted unchanged in the urine. The fraction of erythritol not absorbed is fermented by the gut microflora to intermediate products which are largely absorbed and metabolized. The data support a proposed physiological energy value for erythritol of about 0.5 kcal/g.