Effect of AXOS on the Colon Metabolism in Healthy Volunteers

NCT ID: NCT01656499

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health

Detailed Description

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Conditions

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Gut Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arabinoxylanoligosaccharides (AXOS)

AXOS (2 x 5g WBE/day)

Group Type ACTIVE_COMPARATOR

Arabinoxylanoligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Maltodextrine (placebo)

Maltodextrine (2 x 5g/day)

Group Type PLACEBO_COMPARATOR

Maltodextrine

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Arabinoxylanoligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Maltodextrine

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers
* regular dietary pattern (3 meals/day)
* age: 18-45y
* BMI: 18,5-27 kg/m2

Exclusion Criteria

* intake of antibiotics 1 month prior to the study
* abdominal surgery in the past, with the exception of appendectomy
* intake of medication influencing the gastro-intestinal system 14 days prior to the study
* in treatment at a dietician
* serious liver- or kidney failure
* vegetarians
* intake of pre- and/or probiotics
* Exposure to radioactivity 1 year prior to the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Kristin Verbeke

Professor Kristin Verbeke, Ph. D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Leuven/KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML7245

Identifier Type: -

Identifier Source: org_study_id

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