NCT00852813

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
Last Updated

February 27, 2009

Status Verified

February 1, 2009

First QC Date

February 26, 2009

Last Update Submit

February 26, 2009

Conditions

Healthy

Keywords

toleranceprebioticgastrointestinal effects

Interventions

arabinoxylan-oligosaccharides (AXOS)DIETARY_SUPPLEMENT

intake period: 3 weeks, 10 g/day

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • years
  • regular eating pattern

You may not qualify if:

  • gastrointestinal complaints
  • antibiotic intake
  • medication influencing gut transit or microbiota
  • abdominal surgery
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Research, Laboratory Digestion and Absorption

Leuven, Leuven, 3000, Belgium

Location

Related 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. doi: 10.1080/07315724.2008.10719733.

    PMID: 18978172BACKGROUND

Study Officials

  • Kristin Verbeke, PhD

    KU Leuven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

October 1, 2007

Study Completion

June 1, 2008

Last Updated

February 27, 2009

Record last verified: 2009-02

Locations

BE(1)