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.
RCT Entities:
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.
Authors: Ellen G H M van den Heuvel; Daniel Wils; Wilrike J Pasman; Marie-Hélène Saniez; Alwine F M Kardinaal Journal: Eur J Nutr Date: 2005-02-09 Impact factor: 5.614
Authors: M Vermorel; C Coudray; D Wils; S Sinaud; J C Tressol; C Montaurier; J Vernet; M Brandolini; C Bouteloup-Demange; Y Rayssiguier Journal: Eur J Nutr Date: 2004-01-26 Impact factor: 5.614
Authors: Mark R Hobden; Agustin Martin-Morales; Laetitia Guérin-Deremaux; Daniel Wils; Adele Costabile; Gemma E Walton; Ian Rowland; Orla B Kennedy; Glenn R Gibson Journal: PLoS One Date: 2013-10-24 Impact factor: 3.240