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Effect of AXOS on the Colon Metabolism in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656499
First Posted: August 3, 2012
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristin Verbeke, Katholieke Universiteit Leuven
  Purpose
The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health

Condition Intervention Phase
Gut Health Dietary Supplement: Arabinoxylanoligosaccharides Dietary Supplement: Maltodextrine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of AXOS on the Colon Metabolism in Healthy Volunteers

Further study details as provided by Kristin Verbeke, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Fecal water toxicity [ Time Frame: Participants are followed for 10 weeks, with measurements on 4 specific time points ]

Enrollment: 20
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arabinoxylanoligosaccharides (AXOS)
AXOS (2 x 5g WBE/day)
Dietary Supplement: Arabinoxylanoligosaccharides
Placebo Comparator: Maltodextrine (placebo)
Maltodextrine (2 x 5g/day)
Dietary Supplement: Maltodextrine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656499


Locations
Belgium
UZ Leuven/KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
  More Information

Responsible Party: Kristin Verbeke, Professor Kristin Verbeke, Ph. D., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01656499     History of Changes
Other Study ID Numbers: ML7245
First Submitted: July 30, 2012
First Posted: August 3, 2012
Last Update Posted: January 14, 2015
Last Verified: January 2015