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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of AXOS on the Colon Metabolism in Healthy Volunteers

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Fecal water toxicity [ Time Frame: Participants are followed for 10 weeks, with measurements on 4 specific time points ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2011
Estimated 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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656499

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

No publications provided

Responsible Party: Kristin Verbeke, Professor Kristin Verbeke, Ph. D., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01656499     History of Changes
Other Study ID Numbers: ML7245
Study First Received: July 30, 2012
Last Updated: August 1, 2012
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on April 15, 2014