title: Fibermalt is well tolerated in healthy men and women at intakes up to 60 g/d: a randomized, double-blind, crossover trial.
abstract: In this randomized, double-blind crossover trial, the digestive tolerance of a novel dietary fibre (fibermalt, an indigestible maltose alternan oligosaccharide) was assessed in healthy men and women. Twenty-nine subjects consumed 0 (control), 45 or 60 g of fibre in two doses per day for 2-week treatment periods, each separated by a 2-week washout. Results indicated no differences between treatments in composite gastrointestinal (GI) symptom scores (sum of six GI symptom ratings), individual GI symptoms (nausea, bloating, GI rumbling, gas/flatulence, abdominal pain, diarrhoea), bowel characteristics (frequency, faecal consistency, faecal hardness, straining, discomfort and incomplete evacuation) or average daily faecal output. The symptom scores were consistently low for each treatment period with means averaging below 1 out of a possible range of 0-12 for the composite score. The results of this study suggest that fibermalt is well tolerated at intakes up to 60 g of fibre per day.
authors.affiliation: Biofortis Clinical Research, Addison, IL 60101, USA. kevin.maki@mxns.com
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Maki
authors.forename: Tia M
authors.initials: TM
authors.lastname: Rains
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Kelley
authors.forename: Chad M
authors.initials: CM
authors.lastname: Cook
authors.forename: Arianne L
authors.initials: AL
authors.lastname: Schild
authors.forename: Eva
authors.initials: E
authors.lastname: Gietl
mesh_terms: D000328:Adult; D004043:Dietary Fiber / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology*; D005936:Glucans / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects*; D009844:Oligosaccharides / Q000008:administration & dosage / Q000009:adverse effects*; D012016:Reference Values
chemical_list: D004043:Dietary Fiber; D005936:Glucans; D009844:Oligosaccharides; C439358:alternan; D008320:Maltose