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Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time

NCT01540669 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-01-22

No results posted yet for this study

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.

Conditions

  • Functional Constipation

Interventions

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

Sponsors & Collaborators

  • Sprim Advanced Life Sciences

    collaborator OTHER

  • Danisco

    lead INDUSTRY

Principal Investigators

  • Silvio Danese, MD · Istituto Clinico Humanitas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Italy

Study Locations

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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 NCT01540669 on ClinicalTrials.gov