Gastrointestinal tolerance of VERSAFIBE&[trade] 2470 dietary fiber in humans

Abstract

VERSAFIBE™ 2470 dietary fiber is a high‐fiber resistant starch type 4 that contains 70% total dietary fiber (TDF, AOAC 2009.01 method). The product can be used to add fiber to a variety of bakery applications. This randomized, double‐blind, placebo‐controlled, three‐period crossover trial tested the tolerance of two doses of VERSAFIBE 2470 dietary fiber compared to placebo in 26 healthy adults (0 g/d TDF, 25 g/d TDF, 50 g/d TDF). The 0 g/d TDF treatment (placebo) was 39 g/d AMIOCA® waxy maize starch, which was matched by weight to the 25 g/d TDF dose. Each 2‐week treatment period was separated by a 1‐week wash out. The doses were split and consumed twice per day, 8 hours apart. Subjects collected all bowel movement passed during the final four days of each treatment period. The gastrointestinal (GI) Tolerability Questionnaire was administered at the end of each week (baseline, treatment periods, and washout periods). Subjects recorded bowel habits and rated fecal consistency using the Bristol Stool Scale for seven days during the second week of each period: baseline, treatment 1, treatment 2, and treatment 3. The study was conducted according to GCP Guidelines and the Declaration of Helsinki (2000). An institutional review board (Hummingbird IRB, Cambridge, MA) approved the protocol before initiation of the study, and subjects provided written informed consent before any study procedures were performed. There were no significant differences among treatments in any of the fecal or bowel habit parameters examined, including bowel movement frequency, fecal output, fecal consistency, a composite measure of frequency and consistency, or ratings on the Bristol Stool Scale of fecal hardness, straining, discomfort, or incomplete evacuation. Subjective symptoms scores assessed with the GI Tolerability Questionnaire did not differ for nausea or diarrhea. Subjects reported similar GI symptoms on the 0 g/d TDF dose and the 25 g/d TDF dose, with the exception of GI rumblings. The mean rating for GI rumblings was significantly higher for the 25 g/TDF dose (p = 0.0427 week 1 and p = 0.0355 week 1); however, the mean rating did not exceed “1‐No more than usual” which suggests that the fiber did not affect quality of life. The 50 g/d TDF dose resulted in significantly greater scores for GI rumblings, bloating, abdominal pain, and flatulence compared to 0 g/d TDF. The composite GI tolerability score after one week of treatment was also significantly different among treatments (p = 0.0016). Pairwise comparisons indicated that the 50 g/d TDF treatment had a significantly (p = 0.0011) larger mean [SEM] composite GI tolerability score (4.50 [0.79]) compared to the score of the 0 g/d DF treatment (1.77 [0.39]). The composite GI tolerability score of the 25 g/d TDF treatment (2.88 [0.52]) was not significantly different from either the 0 g/d or 50 g/d TDF condition (p > 0.05). Based on the GI symptoms, VERSAFIBE 2470 dietary fiber is a fermentable fiber and is therefore expected to exert a positive benefit on digestive health. This trial demonstrates that a high dose (25 g/d TDF) of VERSAFIBE 2470 dietary fiber is well‐tolerated in healthy adults.Support or Funding InformationThis study was funded by Ingredion Incorporated, Bridgewater, NJ, USA. Copyright 2016 by Ingredion Incorporated