薬理と治療

Abstract

Objectives This study aimed to investigate the safety of excessive consumption of corn syrup solids containing maltobionic acid（maltobionic acid calcium salt）in healthy Japanese subjects in an open-label, before-after design. Methods Twenty-one Japanese subjects were enrolled, selected according to the study criteria, and were evaluated by a physician. Eligible subjects ingested of corn syrup solids containing matobionic acid 24 g╱day（three to six times more than the regular dosage）for 4 weeks. The follow-up period was for 2 weeks. Safety evaluation included the physical examination, blood analysis, urinalysis, subjective symptoms, and medical questionnaire. Subjects were assessed at baseline, at 2 and 4 weeks after consumption, and at 2 weeks after the study completion. Results All 21 subjects completed the study and were evaluated（11 male, 10 female, mean age and standard deviation of 38.2±8.4 years）. The variability in data from physical examination and blood analysis were within the reference range. Because of corn syrup solids containing maltobionic acid intake, urinalysis results shifted. These data were clinically evaluated and found to be unproblematic. Although minor adverse events observed in subjective symptoms, these were unrelated to this study, and no serious illnesses or adverse events were found by the physician. Conclusion A high dose of up to 24 g╱day of corn syrup solids containing maltobionic acid （three to six times more than the regular dosage）for 4 weeks is safe in healthy Japanese subjects under the conditions of this study.