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Prebiotics Change Microflora and Decrease LPS

NCT ID: NCT02287844

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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

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Prebiotics Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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XOS group

Subjects consumed 6.64 g of a XOS-enriched compound derived from wheat arabinoxylans (5 g of XOS) everyday for 4 weeks.

Group Type EXPERIMENTAL

XOS

Intervention Type OTHER

5 g of XOS everyday for 4 weeks.

INU-XOS group

Subjects consumed 6.64 g of a mixture containing inulin-type fructans, XOS and maltodextrins (3 g of inulin and 1 g of XOS) everyday for 4 weeks.

Group Type EXPERIMENTAL

INU-XOS

Intervention Type OTHER

1 g of XOS and 3 g of inulin everyday for 4 weeks.

Placebo

Subjects consumed 6.64 g of wheat maltodextrins everyday for 4 weeks.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

6.64 g of maltodextrins everyday for 4 weeks.

Interventions

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XOS

5 g of XOS everyday for 4 weeks.

Intervention Type OTHER

INU-XOS

1 g of XOS and 3 g of inulin everyday for 4 weeks.

Intervention Type OTHER

Placebo

6.64 g of maltodextrins everyday for 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Stable weight (+/- 3 kg) for the last 3 months
* Body Mass Index (BMI) between 18.5 and 27 kg/m²
* Consuming between 13 and 18 g of dietary fiber a day
* Student on campus at the Institut Polytechnique LaSalle Beauvais
* Informed consent form signed
* Able to follow the requirement of the study
* Have a social security

Exclusion Criteria

* Has a serious pathology
* Has a gastrointestinal, vesicular or pancreatic disease
* Took an antibiotic or a laxative treatment in the last 6 months
* Surgery of the gastrointestinal tract in the last 12 months
* Orange juice intolerance
* Chronic or recurring diarrhea, constipation or abdominal pain
* Taking drugs known to have an effect on the gastrointestinal, pancreatic and vesicular function
* Recent gastroenteritis or foodborne illness
* Diabetes
* Consuming regularly of probiotics- or prebiotics-enriched products in the last month
* Drinking more than 3 glasses of alcohol a day
* Is deprived of liberty
* Is under judicial protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Polytechnique LaSalle Beauvais

OTHER

Sponsor Role collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel Lecerf

MD, Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institut Polytechnique LaSalle Beauvais

Beauvais, Oise, France

Site Status

Countries

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France

Other Identifiers

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2007-A00273-50

Identifier Type: -

Identifier Source: org_study_id