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NCT00852813 Clinical Trial

Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects

Healthy Clinical Trial

Official title:
Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects: a Randomized, Placebo-Controlled Cross-Over Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00852813
Other study ID # AXOS 002
Secondary ID
Status Completed
Phase Phase 4
First received February 26, 2009
Last updated February 26, 2009
Start date October 2007
Est. completion date June 2008

Study information
Verified date February 2009
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the tolerance of a higher dose of arabinoxylan-oligosaccharides (AXOS) and their prebiotic activity in healthy subjects.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- healthy

- 18-45 years

- regular eating pattern

Exclusion Criteria:

- gastrointestinal complaints

- antibiotic intake

- medication influencing gut transit or microbiota

- abdominal surgery

- pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• arabinoxylan-oligosaccharides (AXOS)
intake period: 3 weeks, 10 g/day

Locations
Country Name City State
Belgium Department of Gastrointestinal Research, Laboratory Digestion and Absorption Leuven

Sponsors (1)
Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Cloetens L, De Preter V, Swennen K, Broekaert WF, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Dose-response effect of arabinoxylooligosaccharides on gastrointestinal motility and on colonic bacterial metabolism in healthy volunteers. J Am Coll Nutr. 2008 Aug;27(4):512-8. — View Citation

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