AIM: We aimed to evaluate the gastro-intestinal tolerance to an indigestible bulking sweetener containing sugar alcohol using a double-blind random cross-over study. METHOD: In order to simulate their usual pattern of consumption, 12 healthy volunteers ingestedmaltitol or sucrose throughout the day, either occasionally (once a week for each sugar, first period) or regularly (every day for two 9 day periods, second period). In both patterns of consumption, daily sugar doses were increased until diarrhea and/or a grade 3 (ie severe) digestive symptom occurred, at which the dose level was defined as the threshold dose (TD). RESULTS: In the first period (occasional consumption), the mean TD was 92+/-6 g with maltitol and 106+/-4 g with sucrose (P=0.059). The mean intensity of digestive symptoms was 1.1 and 1.3, respectively (P=NS). Diarrhea appeared in six and one subjects respectively (P=0.035). In the second period (regular consumption), the mean TD was 93+/-9 g with maltitol and 113+/-7 g with sucrose (P=0.008). The mean intensity of digestive symptoms was 1.7 and 1.2, respectively (P=NS). However, diarrhea appeared in eight and three subjects, respectively (P=0.04). Maltitol and sucrose TDs between the two periods were not different. CONCLUSIONS: Under our experimental conditions, in comparison to sucrose: (a) occasional or regular consumption of maltitol is not associated with severe digestive symptoms; (b) in both patterns of maltitol consumption, diarrhea frequency is higher, but it appeared only for very high doses of maltitol, much greater than those currently used; (c) maltitol does not lead to intestinal flora adaptation after a 9 day period of consumption.
RCT Entities:
AIM: We aimed to evaluate the gastro-intestinal tolerance to an indigestible bulking sweetener containing sugar alcohol using a double-blind random cross-over study. METHOD: In order to simulate their usual pattern of consumption, 12 healthy volunteers ingested maltitol or sucrose throughout the day, either occasionally (once a week for each sugar, first period) or regularly (every day for two 9 day periods, second period). In both patterns of consumption, daily sugar doses were increased until diarrhea and/or a grade 3 (ie severe) digestive symptom occurred, at which the dose level was defined as the threshold dose (TD). RESULTS: In the first period (occasional consumption), the mean TD was 92+/-6 g with maltitol and 106+/-4 g with sucrose (P=0.059). The mean intensity of digestive symptoms was 1.1 and 1.3, respectively (P=NS). Diarrhea appeared in six and one subjects respectively (P=0.035). In the second period (regular consumption), the mean TD was 93+/-9 g with maltitol and 113+/-7 g with sucrose (P=0.008). The mean intensity of digestive symptoms was 1.7 and 1.2, respectively (P=NS). However, diarrhea appeared in eight and three subjects, respectively (P=0.04). Maltitol and sucrose TDs between the two periods were not different. CONCLUSIONS: Under our experimental conditions, in comparison to sucrose: (a) occasional or regular consumption of maltitol is not associated with severe digestive symptoms; (b) in both patterns of maltitol consumption, diarrhea frequency is higher, but it appeared only for very high doses of maltitol, much greater than those currently used; (c) maltitol does not lead to intestinal flora adaptation after a 9 day period of consumption.