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
| Type | Name | Description |
|---|---|---|
| OTHER | XOS | 5 g of XOS everyday for 4 weeks. |
| OTHER | INU-XOS | 1 g of XOS and 3 g of inulin everyday for 4 weeks. |
| OTHER | Placebo | 6.64 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.