NCT01540669

Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time

Dose-ranging Efficacy of 2-week Polydextrose Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebocontrolled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.

Detailed description

Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polydextrose, low dose	4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
DIETARY_SUPPLEMENT	Polydextrose, medium dose	8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
DIETARY_SUPPLEMENT	Polydextrose, high dose	12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
DIETARY_SUPPLEMENT	Placebo powder	Placebo powder will be mixed with beverage and consumed once per day for 2 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-02-29
• Last updated: 2016-01-22

Locations

1 site across 1 country: Italy