Isomaltulose is a natural occurring
disaccharide composed of alpha-1,6-linked
glucose and
fructose. Commercial
isomaltulose is produced from
sucrose by enzymatic rearrangement and has been used as a
sugar in Japan since 1985. It is particularly suitable as a non-cariogenic
sucrose replacement and is favorable in products for diabetics and prediabetic dispositions. In vivo studies with rats and pigs indicate that
isomaltulose is completely hydrolyzed and absorbed in the small intestine. This is supported by in vitro studies showing that intestinal
disaccharidases from various species (including man) can hydrolyze
isomaltulose. The rate of hydrolysis, however, is very slow compared with
sucrose and
maltose. Thus,
blood glucose and
insulin levels in humans after
oral administration rise slower and reach lower maxima than after
sucrose administration. After absorption,
fructose and
glucose are metabolized as typical for these
monosaccharides. From intravenous studies it can be assumed that any systemic
isomaltulose would be hydrolyzed as well, or excreted in urine. In several subchronic toxicity studies, the administration of large doses (up to 7.0 and 8.1 g/kg
body weight/day in male and female rats, respectively) of
isomaltulose, did not result in adverse effects.
Isomaltulose induced neither embryotoxic or teratogenic effects in rat foetuses, nor maternal toxicity at levels up to 7 g/kg
body weight/day.
Isomaltulose was non-mutagenic in the Ames test. As hydrolysis in the small intestine is complete, even high levels of
isomaltulose are well tolerated in animals and humans. In studies with healthy as well as diabetic subjects high doses up to 50 g were tolerated without signs of intestinal discomfort. On the basis of the data reviewed it is concluded that the use of
isomaltulose as an alternative
sugar is as safe as the use of other digestible
sugars consisting of
glucose and
fructose.