TOLERANCE TO SUBCHRONIC, HIGH-DOSE INGESTION OF ERYTHRITOL IN HUMAN VOLUNTEERS

Citation
W. Tetzloff et al., TOLERANCE TO SUBCHRONIC, HIGH-DOSE INGESTION OF ERYTHRITOL IN HUMAN VOLUNTEERS, Regulatory toxicology and pharmacology, 24(2), 1996, pp. 286-295
Citations number
22
Categorie Soggetti
Medicine, Legal","Pharmacology & Pharmacy",Toxicology
ISSN journal
02732300
Volume
24
Issue
2
Year of publication
1996
Part
2
Pages
286 - 295
Database
ISI
SICI code
0273-2300(1996)24:2<286:TTSHIO>2.0.ZU;2-K
Abstract
Erythritol is a sugar alcohol (polyol) which is absorbed from the smal l intestine in substantial amounts, not metabolized in the human body, and therefore excreted in the urine. Erythritol holds promise as a lo w-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 participants consumed erythritol and, for comparison, sucrose for a duration of 7 days each. The daily dose of the test compounds ingested was 0.3 g/kg on Day 1, 0.6 g/kg on Day 2, and 1.0 g/kg on subsequent days. The daily dose was consumed under supervision in five portions, i.e., with the three main meals, a midm orning snack, and during the afternoon. The test compounds were incorp orated into yoghurt, cookies, soft drinks, and chocolate. On each trea tment day, body weight and blood pressure were measured and the partic ipants were interviewed about side effects and their perception of sto ol and urine production. During the last 96 hr of each treatment perio d, urine was collected at 3-hr intervals during the day and for a 9-hr interval overnight for analysis of erythritol and different urinary p arameters. On Days 3 to 7 of each treatment period, the participants w ere institutionalized. Body weights and blood pressure remained stable during the entire study. Signs of gastrointestinal intolerance were n ot seen and stool frequency and appearance were not different between the two treatments. The intake of liquids, which were provided ad libi tum, was generally rather high (32.8 g/kg body wt/day on average) but not different between erythritol and sucrose consumption. Urine output also was high during both treatment periods. About 78% of ingested er ythritol was excreted in the urine which led to a higher urinary osmol ality but did not influence the 24-hr output of creatinine, citrate, u rea, or electrolytes (Na+, K+, Cl-, P-i). The excretion of calcium was slightly higher during the erythritol test period but in absolute ter ms this increase was small. The urinary excretions of albumin, beta(2) -microglobulin, and N-acetylglucosaminidase were slightly elevated dur ing the erythritol test period but they were still well within the phy siological range. None of the observed urinary changes became more pro nounced with increasing duration of the erythritol treatment. In concl usion, the results of the present study demonstrate that the repeated ingestion of erythritol at daily doses of 1 g/kg body wt was well tole rated by humans. (C) 1996 Academic Press, Inc.