Prebiotics Change Microflora and Decrease LPS (PIB)

Pasteur Institute of Lille (IPL)

Status: Completed

Conditions: Prebiotics Effect

Treatments: Other: Placebo; Other: XOS; Other: INU-XOS

Study type: Interventional

Funder types: Other

Identifiers

NCT02287844

2007-A00273-50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

XOS group

Experimental group

Description:

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

Treatment:

Other: XOS

INU-XOS group

Experimental group

Description:

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.

Treatment:

Other: INU-XOS

Placebo

Active Comparator group

Description:

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

Treatment:

Other: Placebo