Clinical Trials Directory

Trials / Completed

CompletedNCT02287844

Prebiotics Change Microflora and Decrease LPS

Xylo-oligosaccharide (XOS) in Combination With Inulin Modulates Both the Intestinal Environment and Immune Status in Healthy Subjects, While XOS Alone Only Shows Prebiotic Properties

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Institut Pasteur de Lille · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.

Detailed description

The study followed a randomized, parallel placebo-controlled double-blind design. A semi-quantitative dietary survey was performed at enrollment in order to assess the usual dietary fiber intake in order to select the target population consuming 13 to 18 g/day. The volunteers were instructed to follow dietary guidelines to maintain their fiber intake during a two-week stabilization phase and then throughout the intervention. As all volunteers were living on-site and taking all meals at the Institut Polytechnique LaSalle Beauvais cafeteria, the content of each meal could be closely controlled during the week. A 3-day dietary survey was performed at the end of the stabilization period and repeated at the end of the intervention in order to assess the stability of the diet. The 60 volunteers were randomly assigned to one of three groups and received daily the intervention for 4 weeks.

Conditions

Interventions

TypeNameDescription
OTHERXOS5 g of XOS everyday for 4 weeks.
OTHERINU-XOS1 g of XOS and 3 g of inulin everyday for 4 weeks.
OTHERPlacebo6.64 g of maltodextrins everyday for 4 weeks.

Timeline

Start date
2008-10-01
Primary completion
2008-12-01
Completion
2008-12-01
First posted
2014-11-11
Last updated
2014-11-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02287844. Inclusion in this directory is not an endorsement.