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Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation

NCT02314936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2018-11-09

Study results available
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Summary

This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.

Conditions

  • Functional Constipation

Interventions

DIETARY_SUPPLEMENT

Litesse powder containing 12 g polydextrose

12 g polydextrose

DIETARY_SUPPLEMENT

Litesse powder containing 8 g polydextrose

8 g polydextrose, 4 g maltodextrin

DIETARY_SUPPLEMENT

Litesse powder containing 4 g polydextrose

4 g polydextrose, 8 g maltodextrin

DIETARY_SUPPLEMENT

Placebo

12 g Maltodextrin

Sponsors & Collaborators

  • DuPont Nutrition and Health

    collaborator INDUSTRY

  • KGK Science Inc.

    lead INDUSTRY

Principal Investigators

  • Tetyana Pelipyagina, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • Canada

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 NCT02314936 on ClinicalTrials.gov