NCT05309837

Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects

A Two-center, Randomized, Double-blind, Placebo Controlled, Parallel Study to Evaluate the Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Tate & Lyle · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Polydextrose (PDX) (8-30g/day) has been reported to increase faecal bulk and consistency, leading to easier stool passage in healthy subjects. Studies on its effect on defaecation frequency and colonic transit time have provided mixed results. The primary objective was to investigate the effect of PDX consumption by mildly constipated subjects on faecal bulk, measured as total faecal wet weight of 4-day collections. Secondary outcomes (faecal dry weight, defaecation frequency, stool consistency, ease of stool passage, total colonic transit time and gastrointestinal symptoms) were also explored. 51 subjects participated in a 4-week, two-center, randomized, double-blind, placebo-controlled, parallel study testing a control (CON) and a PDX treatment (18 g/d included in biscuits and drink mixtures)

Conditions

• Constipation
• Gastrointestinal Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polydextrose	Polydextrose-enriched food products
DIETARY_SUPPLEMENT	placebo-controlled	Control food products

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-05-01
• Completion: 2013-09-19
• First posted: 2022-04-04
• Last updated: 2022-04-04