Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial

Abstract

Constipation is among the most common health impairments in Western countries. This study aimed to determine the effect of the chicory-derived fermentable dietary fiber Orafti^® Inulin on stool frequency in healthy subjects with constipation. The study was conducted according to recent guidance documents for investigating bowel function and used a randomized, double-blind, placebo-controlled, cross-over design with a 2-week wash-out phase. Each study period comprised a run-in phase followed by 4 weeks daily intake of 3 × 4g inulin or maltodextrin (placebo). Forty-four healthy volunteers with constipation documented stool frequency and consistency, gastrointestinal characteristics and quality of life. Consumption of Orafti^® Inulin significantly increased stool frequency compared to placebo (median 4.0 [IQR 2.5–4.5] versus 3.0 [IQR 2.5–4.0] stools/week, p = 0.038). This was accompanied by a softening of stools and trend toward higher satisfaction versus placebo (p = 0.059). In conclusion, Orafti^® Inulin was effective in volunteers with chronic constipation and significantly improved bowel function.

Clinical trial registration: This trial was registered at clinicaltrials.gov as NCT02548247.

Keywords:

• Dietary fiber
• inulin
• constipation
• stool frequency
• bowel function

Acknowledgements

The authors would like to thank all subjects taking part in this trial.

Disclosure statement

AH and ST are employees of BENEO/Südzucker Group. AM, AS and CS are employees of BioTeSys GmbH, Esslingen. The study was sponsored by BENEO GmbH. The sponsor contributed to the discussion of study design and selection of outcome measures prior to study start. Study performance was completely blinded. Data analysis and report generating was undertaken independently from the sponsor.

Funding

The study was funded by BENEO GmbH, Mannheim, Germany, a member of the Südzucker Group. The study results and data contained in the publication have been developed by and/or for BENEO. BENEO reserves the exclusive right to use the results and data for possible Health Claim requests.