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OBJECTIVE:: To determine the tolerance of increasing dosages of an incompletely hydrolysed and/or incompletely absorbed food dextrin coming from wheat starch, NUTRIOSE®FB, at daily levels of 10 and 15?g up to 60 and 80?g, respectively. DESIGN:: A randomized, double-blind, multiple dose, placebo-controlled, combined crossover and parallel trial. SETTING:: The metabolic ward of TNO Nutrition and Food Research. SUBJECTS:: A total of 20 healthy men (age 31.7±9.1?y; BMI 24.5±2.9?kg/m2). INTERVENTION:: One group of 10 subjects consumed on top of their diet 10, 30 and 60?g of NUTRIOSE®FB or maltodextrin (placebo) daily. The other group of 10 subjects consumed 15, 45 and 80?g daily. Each dose was consumed for 7 days. RESULTS:: Compared with placebo, flatulence occurred more frequently over the last 6 days on 30, 60 or 80?g/day of NUTRIOSE®FB (P<0.05). During the last 24?h, that is, days 6-7, of 60 and 80?g/day of NUTRIOSE®FB, the frequency of flatulence was even higher (P<0.05). During the last 24?h on a daily dose of 60?g NUTRIOSE®FB, the frequency of defecation decreased (P<0.05). Bloating occurred more often during the last 24?h on 80?g/day of NUTRIOSE®FB (P<0.05). None of the doses of NUTRIOSE®FB resulted in diarrhoea. Compared to baseline levels, breath H2 excretion, which was only measured after a week with 10 and 15?g of NUTRIOSE®FB daily, increased (P<0.05). However, no difference in area under the curve was found. CONCLUSIONS:: NUTRIOSE®FB is a fermentable carbohydrate and is well tolerated up to a dose of 45?g daily. Higher daily dosages (60 and 80?g) may result in flatulence, but does not result in diarrhoea. SPONSORSHIP:: TNO Nutrition and Food Research was assigned by Roquette Frères to perform the study.European Journal of Clinical Nutrition (2004) 58, 1046-1055. doi:10.1038/sj.ejcn.1601930 [ABSTRACT FROM AUTHOR]