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CONFIDENTIAL<br />
Regulatory Affairs &<br />
Nutrition Communication – AJ/Se<br />
28 May 2008<br />
Page 4 of 16<br />
Various in vitro studies with material from different species (rat, pig, human) addressed the<br />
rate of hydrolysis of isomaltulose versus sucrose or maltose and showed a rate of<br />
hydrolysis of typically less than 25 % that of sucrose (Table 1).<br />
Table 1: Rate of hydrolysis of isomaltulose in vitro<br />
Species Rate of hydrolysis of isomaltulose (%)<br />
Reference<br />
Versus sucrose Versus maltose<br />
Pig 10 – 20 2 – 5 Dahlqvist, 1961<br />
Pig 5.6 4.7 Heinz, 1987<br />
Rat 11.8 4.4 Yamada et al., 1985<br />
Rat 11.4 2.4 Tsuji et al., 1986<br />
Rat 1.8 3.7 Heinz, 1987<br />
Human 44.7 11 Grupp & Siebert, 1978<br />
Human 12.7 9 Ziesenitz, 1986a<br />
Human 26* 8* Ziesenitz, 1986b<br />
Human 16 18 Heinz, 1987<br />
*5 sugars added in a mixed preparation; in all other studies sugars added individually.<br />
Isomaltulose is virtually completely absorbed in the small intestine<br />
The absorption of isomaltulose was observed using various study designs and species.<br />
Recovery of radio labelled isomaltulose was compared to labelled sucrose in a rat study<br />
that showed a similar metabolism of both sugars (Macdonald and Daniel 1983).<br />
Absorption in the small intestine was examined in a study using pigs (60-70 kg bw) with a<br />
re-entrant fistula at the end of the small intestine. With this fistula it was possible to collect<br />
the chyme that arrived at the end of the small intestine. This chyme was analysed for its<br />
content of sugars. The pigs received 20% sucrose or isomaltulose as part of their diet. It<br />
was demonstrated that there was hardly any passage of isomaltulose at the terminal end of<br />
the ileum. Recovery of ingested isomaltulose was less than 3%. Both sugars were almost<br />
completely digested and absorbed in the small intestine. The amounts of end products<br />
(short chain fatty acids) of bacterial fermentation were similar for both sucrose and<br />
isomaltulose, indicating that fermentation in the large intestine was not a significant factor.<br />
Moreover, the flow of wet ileal chyme was identical in the sucrose and isomaltulose group,<br />
demonstrating the absence of non-absorbed and thus osmotically active nutrients (van<br />
Weerden et al 1983).<br />
An ileostomy study performed at the University of Würzburg, Germany, examined digestion<br />
and absorption of isomaltulose in humans in vivo (Gostner et al 2006). The 10 ileostomy<br />
patients consumed 50g isomaltulose in form of a drink (500ml) or a combination of a drink