Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Oct 1996
Gastrointestinal response and plasma and urine determinations in human subjects given erythritol.
This study was undertaken to examine the influence of erythritol on certain plasma and urinary parameters and to assess the gastrointestinal response of humans given erythritol at single oral doses of 0.4 or 0.8 g/kg body wt/day. Three groups of six healthy volunteers each received a midmorning snack containing the equivalent of 0.4 or 0.8 g erythritol/kg body wt or 0.8 g sucrose/kg body wt. A fourth group received no snack and served as a negative control group. ⋯ Plasma and urine erythritol concentrations increased within 2 hr of ingestion in proportion to the amount ingested. Approximately 60% of the erythritol dose was eliminated in the urine within 22 hr. The results of this study demonstrate that ingestion of erythritol at doses of up to 0.8 g/kg body wt does not alter plasma or urine osmolarity or electrolyte balance and is well tolerated by the digestive tract.
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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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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.