The Safety of High-dose Repeated OralIngestion
of Difructose Anhydride III in Healthy Humans Akiko TAMURA1, TakuyaSHIOMI1, Yasuhide OKUHARA1, KohsukeHAYAMIZU1,
Norihiro SHIGEMATSU1, Hiroto KIKUCHI2, FusaoTOMITA3, and Hiroshi HARA3 1Central Research Laboratory, FANCL Co., Ltd.
2Research Center, Nippon Beet Sugar MFG., Co., Ltd.
33Division of Applied Bioscience, Graduate School ofAgriculture We conducted a high-dose, repeated ingestion studyof difructose anhydrideIII (DFAIII) in humans. All subjectsingested 3 g of DFAIII 3 times (9 g) daily for 4 weeks. Blood andurine samples were collected at pre- (day 0), mid-(day 14), andpost- (day 29) ingestion periods. Stool condition and defecationfrequency, diet menu, and the incidents of gastrointestinal andother symptoms were recorded for 6 weeks with the ingestion periodbracketed. Some blood parameters, especially blood osmolarity,varied between day 0 and day 14 or day 29; however,these changeswere not serious. Incidences of some gastrointestinal symptomstended to rise only in the early stage of the ingestion period,though increased defecation frequency and the incidence of diarrheadid not recover completely until the ingestion period wasconcluded. These results show that high-dose, repeated ingestion ofDFAIII could produce transitory diarrhea and some gastrointestinalsymptoms, but no serious adverse effects.
Key words: Difructose anhydride III (DFAIII), Humans, Safety |
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