Prebiotics Change Microflora and Decrease LPS (PIB)

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

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.

Study Overview

• Status: Completed
• Conditions: Prebiotics Effect
• Intervention / Treatment: Other: XOS; Other: INU-XOS; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Oise
    • Beauvais, Oise, France, 60000
      • Institut Polytechnique LaSalle Beauvais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XOS group; Subjects consumed 6.64 g of a XOS-enriched compound derived from wheat arabinoxylans (5 g of XOS) everyday for 4 weeks.	Other: XOS; 5 g of XOS everyday for 4 weeks.
Experimental: 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.	Other: INU-XOS; 1 g of XOS and 3 g of inulin everyday for 4 weeks.
Active Comparator: Placebo; Subjects consumed 6.64 g of wheat maltodextrins everyday for 4 weeks.	Other: Placebo; 6.64 g of maltodextrins everyday for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the intestinal bifidobacterium at 4 weeks.	Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the intestinal bifidobacterium at 2 weeks.	Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).	2 weeks
Change from 2 weeks in the intestinal bifidobacterium at 4 weeks.	Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).	Between 2 and 4 weeks
Change from Baseline in total microbiota and composition in the feces at 4 weeks.	Total bacterial count and specific bacterial profile analyzed by quantitative PCR.	4 weeks
Change from Baseline in total microbiota and composition in the feces at 2 weeks.	Total bacterial count and specific bacterial profile analyzed by quantitative PCR.	2 weeks
Change from 2 weeks in total microbiota and composition in the feces at 4 weeks.	Total bacterial count and specific bacterial profile analyzed by quantitative PCR.	Between 2 and 4 weeks
Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks	Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.	4 weeks
Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 2 weeks	Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.	2 weeks
Change from 2 weeks of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks	Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.	Between 2 and 4 weeks
Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.		4 weeks
Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 2 weeks.		2 weeks
Change from 2 weeks in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.		Between 2 and 4 weeks
Change from Baseline in the phenol and p-Cresol in the feces at 4 weeks.		4 weeks
Change from Baseline in the phenol and p-Cresol in the feces at 2 weeks.		2 weeks
Change from 2 weeks in the phenol and p-Cresol in the feces at 4 weeks.		Between 2 and 4 weeks
Change from Baseline in the faecal pH and dry matter at 4 weeks.		4 weeks
Change from Baseline in the faecal pH and dry matter at 2 weeks.		2 weeks
Change from 2 weeks in the faecal pH and dry matter at 4 weeks.		Between 2 and 4 weeks
Change from Baseline in secretory Immunoglobulin A (IgA) at 4 weeks.	Measured with s-IgA ELISA kit.	4 weeks
Change from Baseline in secretory Immunoglobulin A (IgA) at 2 weeks.	Measured with s-IgA ELISA kit.	2 weeks
Change from 2 weeks in secretory Immunoglobulin A (IgA) at 4 weeks.	Measured with s-IgA ELISA kit.	Between 2 and 4 weeks
Change from Baseline in cytokines at 4 weeks	Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10	4 weeks
Change from Baseline in cytokines at 2 weeks	Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10	2 weeks
Change from 2 weeks in cytokines at 4 weeks	Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10	Between 2 and 4 weeks
Change from Baseline in dietary intakes at 4 weeks	Data extracted from a 3-day food diary.	4 weeks
Change from Baseline in dietary intakes at 2 weeks	Data extracted from a 3-day food diary.	2 weeks
Change from 2 weeks in dietary intakes at 4 weeks	Data extracted from a 3-day food diary.	Between 2 and 4 weeks
Change from Baseline of circulating lipopolysaccharides (LPS) at 4 weeks.	Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.	4 weeks
Change from Baseline of circulating lipopolysaccharides (LPS) at 2 weeks.	Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.	2 weeks
Change from 2 weeks of circulating lipopolysaccharides (LPS) at 4 weeks.	Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.	Between 2 and 4 weeks
Change from Baseline in the subjects' tolerance to the test products at 4 weeks.	Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm).Stool frequency (stool per day).	4 weeks
Change from Baseline in the subjects' tolerance to the test products at 2 weeks.	Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm). Stool frequency (stool per day).	2 weeks
Change from 2 weeks in the subjects' tolerance to the test products at 4 weeks.	Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm). Stool frequency (stool per day).	Between 2 and 4 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Change from Selection (at least 2 weeks before Baseline) in Weight, Height, BMI, Blood pressure, Heart rate at 4 weeks	4weeks
Change from Selection (at least 2 weeks before Baseline) in Weight, Height, BMI, Blood pressure, Heart rate at 2 weeks	2 weeks
Change from 2 weeks in Weight, Height, BMI, Blood pressure, Heart rate at 4 weeks	Between 2 and 4 weeks

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille
• Collaborators: Institut Polytechnique LaSalle Beauvais

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Estimate): November 17, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Cytokines; Immunonutrition; Prebiotics; Lipopolysaccharides; Xylo-oligosaccharides
• Other Study ID Numbers: 2007-A00273-50