A tolerance study of maltitol in Chinese healthy subjects: a multicenter, simple-blind, placebo-controlled study

Abstract

Abstract Objectives: Our aim was to evaluate the gastrointestinal tolerance of maltitol in Chinese individuals, and to explore the gastrointestinal reactions, and small intestine bacterial overgrowth (SIBO). Methods: 132 healthy subjects from three cities were enrolled in the 6 weeks’ study. All subjects were prescribed a lactulose hydrogen breath test to determine SIBO before the study. The maltitol-containing cookies (MC) with each piece of MC containing 2.5 g maltitol and sucrose-containing cookies (SC) with each piece of SC containing 3.6 g sucrose were prepared and provided. Half of subjects firstly consumed 3 pieces MC and the others consumed 3 pieces SC at the first week, then switched at the second week. All subjects consumed 5 pieces MC at the third week and consumed 7 pieces MC at the fourth week. Half of subjects consumed 10 pieces MC and the others consumed 10 pieces SC at the fifth week, then switched at the sixth week. After consuming the cookies each time, all subjects were asked to fill questionnaire to record if they experienced any gastrointestinal reactions. Results: The incidence of gastrointestinal reactions increases with the intake of maltitol dose and no significant difference in gastrointestinal reactions between maltitol cookies and sucrose cookies with the 3 pieces consumed. There was a significant difference in gastrointestinal reaction between the two types of cookies when the intake reached 10 pieces (P<0.0001). The incidence of gastrointestinal reactions was significantly different between the positive and negative lactulose hydrogen breath conditions (P<0.0001) and negative hydrogen breath test were more likely to experience gastrointestinal reactions (Z=5.2088). Conclusion: Chinese individuals have the lower tolerance threshold for maltitol (17.5 g) as compared to the individuals in other countries. The ethnic differences should be taken into account in the evaluation ad regulations of safe dosages for maltitol in future.