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
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.