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

NCT05309837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-04-04

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Polydextrose

Polydextrose-enriched food products

DIETARY_SUPPLEMENT

placebo-controlled

Control food products

Sponsors & Collaborators

  • Oy Foodfiles Ltd

    collaborator OTHER

  • Tate & Lyle

    lead INDUSTRY

Principal Investigators

  • Essi Sarkkinen, PhD · Oy Foodfiles Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-05-31
Completion
2013-09-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309837 on ClinicalTrials.gov