Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects

This study has been completed.

First Received on February 26, 2009. No Changes Posted

Sponsor:	Katholieke Universiteit Leuven
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00852813

Purpose

The purpose of the study is to evaluate the tolerance of a higher dose of arabinoxylan-oligosaccharides (AXOS) and their prebiotic activity in healthy subjects.

Condition	Intervention	Phase
Healthy	Dietary Supplement: arabinoxylan-oligosaccharides (AXOS)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects: a Randomized, Placebo-Controlled Cross-Over Study

Further study details as provided by Katholieke Universiteit Leuven:

Enrollment:	20
Study Start Date:	October 2007
Study Completion Date:	June 2008

Intervention Details:

intake period: 3 weeks, 10 g/day

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy
18-45 years
regular eating pattern

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852813

Locations

Belgium
Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Leuven, Belgium, 3000

Sponsors and Collaborators

Katholieke Universiteit Leuven

Investigators

Study Director:

Kristin Verbeke, PhD

Katholieke Universiteit Leuven

More Information

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.

Responsible Party:	Kristin verbeke, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00852813 History of Changes
Other Study ID Numbers:	AXOS 002
Study First Received:	February 26, 2009
Last Updated:	February 26, 2009
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Katholieke Universiteit Leuven:

tolerance
prebiotic
gastrointestinal effects

ClinicalTrials.gov processed this record on May 23, 2012