NCT01656499

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

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

March 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

July 30, 2012

Last Update Submit

January 13, 2015

Conditions

Gut Health

Outcome Measures

Primary Outcomes (1)

  • Fecal water toxicity

    Participants are followed for 10 weeks, with measurements on 4 specific time points

Study Arms (2)

Arabinoxylanoligosaccharides (AXOS)

ACTIVE COMPARATOR

AXOS (2 x 5g WBE/day)

Dietary Supplement: Arabinoxylanoligosaccharides

Maltodextrine (placebo)

PLACEBO COMPARATOR

Maltodextrine (2 x 5g/day)

Dietary Supplement: Maltodextrine

Interventions

ArabinoxylanoligosaccharidesDIETARY_SUPPLEMENT
Arabinoxylanoligosaccharides (AXOS)
MaltodextrineDIETARY_SUPPLEMENT
Maltodextrine (placebo)

Eligibility Criteria

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

You may qualify if:

  • healthy volunteers
  • regular dietary pattern (3 meals/day)
  • age: 18-45y
  • BMI: 18,5-27 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven/KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Kristin Verbeke, Ph. D.

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 3, 2012

Study Start

March 1, 2011

Primary Completion

July 1, 2011

Study Completion

September 1, 2012

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

BE(1)