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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
July 30, 2012
August 3, 2012
January 14, 2015
March 2011
July 2011   (Final data collection date for primary outcome measure)
Fecal water toxicity [ Time Frame: Participants are followed for 10 weeks, with measurements on 4 specific time points ]
Same as current
Complete list of historical versions of study NCT01656499 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Effect of AXOS on the Colon Metabolism in Healthy Volunteers
Effect of AXOS on the Colon Metabolism in Healthy Volunteers
The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Gut Health
  • Dietary Supplement: Arabinoxylanoligosaccharides
  • Dietary Supplement: Maltodextrine
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2012
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01656499
ML7245
Yes
Not Provided
Not Provided
Kristin Verbeke, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Not Provided
Katholieke Universiteit Leuven
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP