Title: Alternative Sweeteners

454 Richards and Dexter
activity, although the mean enzymatic activity of these patients in one study was
lower than controls (68).
Cerda and coworkers reported that in non-insulin-dependent diabetic patients
with chronic pancreatic insufficiency, there was approximately a twofold
increase in trehalase and other disaccharidases (69). Patients with chronic renal
failure appear to have reduced levels of trehalase, but the reduction appears to
be less than for other disaccharides (70). The more common condition of lactase
deficiency (lactose intolerance) has not been shown to be correlated with a deficiency
of trehalase in the general population (71). From this information, it appears
that the consumption of trehalose under various conditions presents no more
risk than any other disaccharide in a normal diet.
XVII. SAFETY STUDIES
Trehalose is considered a natural sugar for which humans have evolved and maintained
an intestinal disaccharidase. Because trehalose is now only a minor component
of the human diet, little interest has been shown in studying possible effects
of higher consumption. In the early 1990s, Quadrant Holdings of Cambridge,
England, began investigating the possible use of trehalose for the health and food
industry and commissioned seven toxicological studies. With the advent of the
enzymatic production method of HBC and the subsequent reduction in cost, several
additional safety studies were initiated. At present, none of the studies summarized
in the following have been published; however, a number of them have
been submitted for publication in 2000.
A. Mouse Micronucleus, Chromosome Aberration, and
Bacterial Mutation Assays
All studies were performed by standard methods using trehalose (5, HBC, unpublished
data, 1997, 1997, 1995). Peak dosing concentrations for each assay were
5000 mg/kg, 5000 µg/ml and 5000 µg/plate, respectively. On the basis of the
criteria established by the protocol, it was concluded that trehalose did not show
a positive response (negative treatment effect) in any of the test systems.
B. Single Dose Oral Toxicity
Four studies were performed on mice, rats, and beagle dogs. The first study was
performed on rats using trehalose produced by HBC (HBC, unpublished data,
1995). The remaining three studies were performed using pharmaceutical grade
trehalose produced by Pfanstiehl Laboratories, Inc. (Quadrant Holdings, unpublished
data, 1994). The results are provided in Table 7.