title: 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.
authors.affiliation: a Cargill Incorporated , Wayzata , MN , USA ;
authors.forename: Christine M
authors.initials: CM
authors.lastname: Crincoli
authors.affiliation: a Cargill Incorporated , Wayzata , MN , USA ;
authors.forename: Vicenta
authors.initials: V
authors.lastname: Garcia-Campayo
authors.affiliation: b Toxicology Regulatory Services , Charlottesville , VA , USA ;
authors.forename: Marisa O
authors.initials: MO
authors.lastname: Rihner
authors.affiliation: b Toxicology Regulatory Services , Charlottesville , VA , USA ;
authors.forename: Andrey I
authors.initials: AI
authors.lastname: Nikiforov
authors.affiliation: c Biofortis Innovation Services , Addison , IL , USA.
authors.forename: DeAnn
authors.initials: D
authors.lastname: Liska
authors.affiliation: a Cargill Incorporated , Wayzata , MN , USA ;
authors.forename: Jennifer L G
authors.initials: JL
authors.lastname: van de Ligt
mesh_terms: D015746:Abdominal Pain / Q000175:diagnosis / Q000209:etiology; D000293:Adolescent; D000328:Adult; D001066:Appetite / Q000187:drug effects; D015992:Body Mass Index; D018592:Cross-Over Studies; D003672:Defecation; D004043:Dietary Fiber / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005414:Flatulence / Q000175:diagnosis / Q000209:etiology; D005767:Gastrointestinal Diseases / Q000175:diagnosis / Q000209:etiology; D041981:Gastrointestinal Tract / Q000378:metabolism*; D005936:Glucans / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D013213:Starch / Q000008:administration & dosage* / Q000009:adverse effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004043:Dietary Fiber; D005936:Glucans; D013213:Starch; C033375:polydextrose
keywords: digestive tolerance; gluco-oligosaccharide; polydextrose