Clinical trial NCT02287844: Prebiotics Change Microflora and Decrease LPS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prebiotics Effect
Keywords: Xylo-oligosaccharides
Immunonutrition
Prebiotics
Lipopolysaccharides
Cytokines
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
Collaborators: name: Institut Polytechnique LaSalle Beauvais
First posted: 2014-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the intestinal bifidobacterium at 4 weeks.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from Baseline in the intestinal bifidobacterium at 2 weeks.
timeFrame: 2 weeks
measure: Change from 2 weeks in the intestinal bifidobacterium at 4 weeks.
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline in total microbiota and composition in the feces at 4 weeks.
timeFrame: 4 weeks
measure: Change from Baseline in total microbiota and composition in the feces at 2 weeks.
timeFrame: 2 weeks
measure: Change from 2 weeks in total microbiota and composition in the feces at 4 weeks.
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks
timeFrame: 4 weeks
measure: Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 2 weeks
timeFrame: 2 weeks
measure: Change from 2 weeks of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.
timeFrame: 4 weeks
measure: Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 2 weeks.
timeFrame: 2 weeks
measure: Change from 2 weeks in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline in the phenol and p-Cresol in the feces at 4 weeks.
timeFrame: 4 weeks
measure: Change from Baseline in the phenol and p-Cresol in the feces at 2 weeks.
timeFrame: 2 weeks
measure: Change from 2 weeks in the phenol and p-Cresol in the feces at 4 weeks.
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline in the faecal pH and dry matter at 4 weeks.
timeFrame: 4 weeks
measure: Change from Baseline in the faecal pH and dry matter at 2 weeks.
timeFrame: 2 weeks
measure: Change from 2 weeks in the faecal pH and dry matter at 4 weeks.
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline in secretory Immunoglobulin A (IgA) at 4 weeks.
timeFrame: 4 weeks
measure: Change from Baseline in secretory Immunoglobulin A (IgA) at 2 weeks.
timeFrame: 2 weeks
measure: Change from 2 weeks in secretory Immunoglobulin A (IgA) at 4 weeks.
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline in cytokines at 4 weeks
timeFrame: 4 weeks
measure: Change from Baseline in cytokines at 2 weeks
timeFrame: 2 weeks
measure: Change from 2 weeks in cytokines at 4 weeks
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline in dietary intakes at 4 weeks
timeFrame: 4 weeks
measure: Change from Baseline in dietary intakes at 2 weeks
timeFrame: 2 weeks
measure: Change from 2 weeks in dietary intakes at 4 weeks
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline of circulating lipopolysaccharides (LPS) at 4 weeks.
timeFrame: 4 weeks
measure: Change from Baseline of circulating lipopolysaccharides (LPS) at 2 weeks.
timeFrame: 2 weeks
measure: Change from 2 weeks of circulating lipopolysaccharides (LPS) at 4 weeks.
timeFrame: Between 2 and 4 weeks
measure: Change from Baseline in the subjects' tolerance to the test products at 4 weeks.
timeFrame: 4 weeks
measure: Change from Baseline in the subjects' tolerance to the test products at 2 weeks.
timeFrame: 2 weeks
measure: Change from 2 weeks in the subjects' tolerance to the test products at 4 weeks.
timeFrame: Between 2 and 4 weeks
Other outcomes:
measure: Change from Selection (at least 2 weeks before Baseline) in Weight, Height, BMI, Blood pressure, Heart rate at 4 weeks
timeFrame: 4weeks
measure: Change from Selection (at least 2 weeks before Baseline) in Weight, Height, BMI, Blood pressure, Heart rate at 2 weeks
timeFrame: 2 weeks
measure: Change from 2 weeks in Weight, Height, BMI, Blood pressure, Heart rate at 4 weeks
timeFrame: Between 2 and 4 weeks
Locations:
city: Beauvais
country: France
facility: Institut Polytechnique LaSalle Beauvais
state: Oise
Study officials:
References: