Effect of AXOS on the Colon Metabolism in Healthy Volunteers

Phase 2

Completed

• Conditions: Gut Health

• Registration Number: NCT01656499
• Lead Sponsor: KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-07
• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-03
• Study Completion: 2012-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fecal water toxicity	Participants are followed for 10 weeks, with measurements on 4 specific time points

Trial Locations

Locations (1)

UZ Leuven/KU Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium