Effect of AXOS on the Colon Metabolism in Healthy Volunteers

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Kristin Verbeke, Katholieke Universiteit Leuven

ClinicalTrials.gov Identifier:

NCT01656499

First received: July 30, 2012

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 30, 2012
Last Updated Date	August 1, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 1, 2012)	Fecal water toxicity [ Time Frame: Participants are followed for 10 weeks, with measurements on 4 specific time points ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01656499 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	Effect of AXOS on the Colon Metabolism in Healthy Volunteers
Official Title ^ICMJE	Effect of AXOS on the Colon Metabolism in Healthy Volunteers
Brief Summary	The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Gut Health
Intervention ^ICMJE	Dietary Supplement: Arabinoxylanoligosaccharides Dietary Supplement: Maltodextrine
Study Arm (s)	Active Comparator: Arabinoxylanoligosaccharides (AXOS) AXOS (2 x 5g WBE/day) Intervention: Dietary Supplement: Arabinoxylanoligosaccharides Placebo Comparator: Maltodextrine (placebo) Maltodextrine (2 x 5g/day) Intervention: Dietary Supplement: Maltodextrine
Publications *	Not Provided
* 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	Active, not recruiting
Enrollment ^ICMJE	20
Estimated Completion Date	September 2012
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
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	NCT01656499
Other Study ID Numbers ^ICMJE	ML7245
Has Data Monitoring Committee	Yes
Responsible Party	Kristin Verbeke, Katholieke Universiteit Leuven
Study Sponsor ^ICMJE	Katholieke Universiteit Leuven
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Katholieke Universiteit Leuven
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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