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NCT01656499 Clinical Trial

Effect of AXOS on the Colon Metabolism in Healthy Volunteers

Gut Health Clinical Trial

Official title:
Effect of AXOS on the Colon Metabolism in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01656499
Other study ID # ML7245
Secondary ID
Status Completed
Phase Phase 2
First received July 30, 2012
Last updated January 13, 2015
Start date March 2011
Est. completion date September 2012

Study information
Verified date January 2015
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2012
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Arabinoxylanoligosaccharides

• Maltodextrine

Locations
Country Name City State
Belgium UZ Leuven/KU Leuven Leuven Vlaams-Brabant

Sponsors (1)
Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fecal water toxicity Participants are followed for 10 weeks, with measurements on 4 specific time points No
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