title: Short-term digestive tolerance of different doses of NUTRIOSE FB, a food dextrin, in adult men.
abstract: 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.
  
  
  METHODS
  A randomized, double-blind, multiple dose, placebo-controlled, combined crossover and parallel trial.
  
  
  METHODS
  The metabolic ward of TNO Nutrition and Food Research.
  
  
  METHODS
  A total of 20 healthy men (age 31.7 +/- 9.1 y; BMI 24.5 +/- 2.9 kg/m2).
  
  
  METHODS
  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.
  
  
  BACKGROUND
  TNO Nutrition and Food Research was assigned by Roquette Frères to perform the study.
authors.affiliation: TNO Nutrition and Food Research, Department of Nutritional Physiology, Zeist, Netherlands.
authors.forename: E G H M
authors.initials: EG
authors.lastname: van den Heuvel
authors.forename: D
authors.initials: D
authors.lastname: Wils
authors.forename: W J
authors.initials: WJ
authors.lastname: Pasman
authors.forename: M
authors.initials: M
authors.lastname: Bakker
authors.forename: M-H
authors.initials: MH
authors.lastname: Saniez
authors.forename: A F M
authors.initials: AF
authors.lastname: Kardinaal
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D003672:Defecation / Q000187:drug effects*; D003912:Dextrins / Q000008:administration & dosage / Q000378:metabolism / Q000493:pharmacokinetics* / Q000494:pharmacology; D003967:Diarrhea / Q000453:epidemiology / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005285:Fermentation; D005414:Flatulence / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects*; D008297:Male; D008875:Middle Aged
chemical_list: D003912:Dextrins