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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
  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 May 23, 2013