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.

Keywords::

• fibre
• oligosaccharides
• fibermalt
• tolerance

Acknowledgements

The authors thank all Biofortis Clinical Research clinic staff for assistance with data collection and analysis.

Declaration of interest : This study was funded by aevotis GmbH, Potsdam, Germany. K.C.M., T.M.R., C.M.C. and A.L.S. are employees of Biofortis Clinical Research, Addison, IL, USA, which has received research grant support and consulting fees from aevotis GmbH, the manufacturer of the product studied. E-G- is an employee of aevotis GmbH. The authors alone are responsible for the content and writing of the paper.