ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of AXOS on the Colon Metabolism in Healthy Volunteers

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.
ClinicalTrials.gov Identifier: NCT01656499
Recruitment Status : Completed
First Posted : August 3, 2012
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Kristin Verbeke, Katholieke Universiteit Leuven

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

Condition or disease Intervention/treatment Phase
Gut Health Dietary Supplement: Arabinoxylanoligosaccharides Dietary Supplement: Maltodextrine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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 Posted: August 3, 2012    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015