Prebiotics Change Microflora and Decrease LPS

Study Overview
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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.

Official Title
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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

Conditions
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Prebiotics Effect

Intervention / Treatment
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* Other: XOS
* Other: INU-XOS
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xylo-oligosaccharides, Immunonutrition, Prebiotics, Lipopolysaccharides, Cytokines