Evaluation of the gastrointestinal tolerability of corn starch fiber, a novel dietary fiber, in two independent randomized, double-blind, crossover studies in healthy men and women

Abstract

Two independent clinical studies were conducted to compare the gastrointestinal (GI) tolerability of corn starch fiber, a novel dietary fiber, at up to 50 g/day (single-dose study) or 90 g/day (multiple-serving study) with a negative control (no fiber) and a positive control (50 or 90 g polydextrose, for single- and multiple-serving studies, respectively) in generally healthy study volunteers. Flatulence and borborygmus were the primary symptoms reported at the higher doses of corn starch fiber and for the positive control interventions. Bowel movements were increased over 48 h with corn starch fiber at 90 g. Thresholds for mild GI effects were established at 30 g as a single dose and 60 g as multiple servings spread over the day. Other than moderate abdominal pain and mild increased appetite in one subject at 90-g corn starch fiber, no test article-related adverse events were reported.

Keywords:

• digestive tolerance
• gluco-oligosaccharide
• polydextrose

Acknowledgements

The authors thank Teri Paeschke, Ted Zheng, and Betsy Jones (Cargill) for their help in test article generation, analysis, and sample preparation; Valerie Kaden, Kathleen Kelley, MD, Arianne Schild, MS, and Sébastien Leuillet, MS (Biofortis) for his/her assistance in the study design, conduct, and analysis; and Benjamin L. Burruss (TRS) for his assistance in the review and finalization of the study reports and manuscript.

Disclosure statement

Authors van de Ligt, Garcia-Campayo, and Crincoli are employees of Cargill, the funding sponsor of this study. Authors Rihner and Nikiforov are consultants to Cargill, the study sponsor. Author Liska is an employee of Biofortis Innovation Services which received funding from Cargill to perform the study.