Evaluation of digestive tolerance of a soluble corn fibre

• Published in: Journal of human nutrition and dietetics Vol. 25; no. 5; pp. 488 - 496
• Main Authors: Housez, B., Cazaubiel, M., Vergara, C., Bard, J.-M., Adam, A., Einerhand, A., Samuel, P.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.10.2012; Blackwell
• Subjects: Adolescent; Adult; Aged; Biological and medical sciences; Cross-Over Studies; Defecation - drug effects; Defecation - physiology; Dietary fiber; Dietary Fiber - administration & dosage; Dietary Fiber - pharmacology; dietary fibre; Dietary supplements; Digestive system; Digestive System - drug effects; Dose-Response Relationship, Drug; Double-Blind Method; Feces - chemistry; Feeding. Feeding behavior; Female; Flatulence - epidemiology; Fundamental and applied biological sciences. Psychology; Gastrointestinal Motility - drug effects; gastrointestinal tolerance; Humans; inulin; Inulin - administration & dosage; Inulin - pharmacology; Male; Middle Aged; Solubility; soluble gluco fibre; Vertebrates: anatomy and physiology, studies on body, several organs or systems; Young Adult; Zea mays; Human; Evaluation; Digestive system; Inulin; Corn; Tolerance; soluble gluco fibre; dietary fibre; Gastrointestinal; Prebiotic; gastrointestinal tolerance
• ISSN: 0952-3871; 1365-277X
• DOI: 10.1111/j.1365-277X.2012.01252.x

Background:  To assess consumers’ acceptance of a new fibre, it is essential to evaluate its digestive tolerance after ingestion. We aimed to determine the tolerance of increasing dosages of Promitor™ Soluble Gluco Fibre (SGF; Tate&Lyle, Hoffman Estates, IL, USA) up to 70 g fibre per day using a validated gastrointestinal composite score. Methods:  A composite score of gastrointestinal tolerance integrating gastrointestinal symptoms, stool frequency and consistency was applied. To statistically validate this composite score, the gastrointestinal tolerance of inulin (10 g versus 20 g containing, respectively, 9 g versus 18 g of fibre) was assessed in 18 healthy volunteers in a randomised double‐blind placebo‐controlled cross‐over study. Second, in a double‐blind placebo‐controlled cross‐over study with 20 healthy volunteers, the gastrointestinal tolerance of SGF in both acute and ‘spread over the day’ conditions of consumption was assessed. Results:  By contrast to 10 g, 20 g of inulin demonstrated a significant difference in composite score compared to placebo [P < 0.001, difference = 7.6; 95% confidence interval (CI) = 3.8–11.3]. These values were considered as reference during the second study. In acute conditions, 40 g of SGF fibre was the highest (threshold) dose tested that indicates the digestive tolerance criteria (difference from placebo on the composite score <7.6 and upper limit of the 95% CI <11.3); this is twice the amount tolerated for inulin. In ‘spread over the day’ conditions, 65 g of SGF fibre was the threshold dose (P < 0.001, difference = 6.5; 95% CI = 3.4–9.5). Conclusions:  The results of the present study demonstrate that 40 g of SGF fibre, when consumed as a single dose, and 65 g of SGF fibre, when consumed in multiple‐doses, across the day are well‐tolerated by healthy volunteers.