Effect of AXOS on the Colon Metabolism in Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Katholieke Universiteit Leuven.
Recruitment status was  Active, not recruiting
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

July 30, 2012
August 1, 2012
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01656499 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.
 
Active, not recruiting
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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01656499
ML7245
Yes
Kristin Verbeke, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Not Provided
Katholieke Universiteit Leuven
August 2012

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