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Objective:To determine the gastrointestinal (GI) tolerance of NUTRIOSE®FB in men.Design:A randomized, placebo-controlled, parallel, double-blind study.Setting:The metabolic ward of TNO Quality of Life.Subjects:Forty-eight subjects started the study: 16 men participated in one of the three treatments. Subjects consumed either 22.5 g of pure maltodextrin (Glucidex®6), or 30 or 45 g of the dextrin NUTRIOSE®FB daily for 4–5 weeks. Forty-three subjects completed the study (age: 34.7±8.2 years; BMI 24.9±3.3 kg m2).Measurements:Tolerance of NUTRIOSE®FB was examined with a GI complaints questionnaire; effectiveness on colonic flora was examined by faecal analysis; fermentation by breath hydrogen excretion measurement. Furthermore, the effect on body weight (BW), energy intake and blood parameters were examined in the study.Results:Both doses of NUTRIOSE®FB were very well tolerated and GI complaints hardly differed from the placebo treatment. No diarrhoea was reported due to NUTRIOSE®FB supplementation. In the course of the study, some habituation and adaptation of GI symptoms were found. Fermentation and faecal characteristics (pH and enzyme activity) were significantly positively affected with NUTRIOSE®FB treatment. Body weight in both NUTRIOSE®FB groups remained stable over time, although the placebo-treated group showed a small increase in BW (Δday35−1 0.8±1.0 kg) (P=0.07). However, total food intake and macronutrient composition of the diet remained the same throughout the study. No significant differences were found between the three treatment groups in hunger and satiety scores and food preferences.Conclusions:Long-term supplementation of 30 or 45 g of the dextrin NUTRIOSE®FB per day was well tolerated, and may act as a pre-biotic supplement.Sponsorship:TNO Quality of Life was assigned by Roquette Frères to perform the study.European Journal of Clinical Nutrition (2006) 60, 1024–1034. doi:10.1038/sj.ejcn.1602418; published online 15 February 2006 [ABSTRACT FROM AUTHOR]

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]