Effects of Arabinoxylan-Oligosaccharides Compared to Other Prebiotics in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by:

Katholieke Universiteit Leuven

ClinicalTrials.gov Identifier:

NCT00853034

First received: February 25, 2009

Last updated: February 26, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 25, 2009

Last Updated Date

February 26, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00853034 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Arabinoxylan-Oligosaccharides Compared to Other Prebiotics in Healthy Subjects

Official Title ^ICMJE

Effects of Arabinoxylan-Oligosaccharides on Colonic Metabolism and Microbial Composition Compared to Other Prebiotics in Healthy Subjects

Brief Summary

The purpose of the study is to evaluate the effects of arabinoxylan-oligosaccharides (AXOS) on the colonic metabolism and microbial composition, and to compare these effects with the reference prebiotic fructo-oligosaccharide enriched inulin.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Dietary Supplement: FOS-IN
prebiotic fructo-oligosaccharide enriched inulin

intake period: 2 weeks, 1.25 or 2.50g every morning and evening

Other Name: Synergy1, Orafti, Tienen
Dietary Supplement: AXOS
arabinoxylan-oligosaccharides (AXOS)

intake period: 2 weeks, 1.25 or 2.50g every morning and evening

Study Arm (s)

Active Comparator: FOS-IN
prebiotic fructo-oligosaccharide enriched inulin

Intervention: Dietary Supplement: FOS-IN
Experimental: AXOS
arabinoxylan-oligosaccharides (AXOS)

Intervention: Dietary Supplement: AXOS

Publications *

Cloetens L, De Preter V, Swennen K, Broekaert WF, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Dose-response effect of arabinoxylooligosaccharides on gastrointestinal motility and on colonic bacterial metabolism in healthy volunteers. J Am Coll Nutr. 2008 Aug;27(4):512-8.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

healthy
18-45 years
regular eating pattern

Exclusion Criteria:

gastrointestinal complaints
antibiotic intake
medication influencing gut transit or microbiota
abdominal surgery
pregnancy

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00853034

Other Study ID Numbers ^ICMJE

AXOS 001

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Katholieke Universiteit Leuven

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kristin Verbeke, PhD

Katholieke Universiteit Leuven

Information Provided By

Katholieke Universiteit Leuven

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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