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Completed

NCT Number: NCT02287844

Prebiotics Change Microflora and Decrease LPS

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.

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Key information

Conditions

Prebiotics Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Polytechnique LaSalle Beauvais

Beauvais, Oise, 60000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XOS

Other

5 g of XOS everyday for 4 weeks.

INU-XOS

Other

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

Placebo

Other

6.64 g of maltodextrins everyday for 4 weeks.

Primary outcomes

  1. Change from Baseline in the intestinal bifidobacterium at 4 weeks.

    Time frame: 4 weeks

    Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).

Secondary outcomes

  1. Change from Baseline in the intestinal bifidobacterium at 2 weeks.

    Time frame: 2 weeks

    Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).

  2. Change from 2 weeks in the intestinal bifidobacterium at 4 weeks.

    Time frame: Between 2 and 4 weeks

    Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).

  3. Change from Baseline in total microbiota and composition in the feces at 4 weeks.

    Time frame: 4 weeks

    Total bacterial count and specific bacterial profile analyzed by quantitative PCR.

  4. Change from Baseline in total microbiota and composition in the feces at 2 weeks.

    Time frame: 2 weeks

    Total bacterial count and specific bacterial profile analyzed by quantitative PCR.

  5. Change from 2 weeks in total microbiota and composition in the feces at 4 weeks.

    Time frame: Between 2 and 4 weeks

    Total bacterial count and specific bacterial profile analyzed by quantitative PCR.

  6. Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks

    Time frame: 4 weeks

    Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.

  7. Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 2 weeks

    Time frame: 2 weeks

    Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.

  8. Change from 2 weeks of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks

    Time frame: Between 2 and 4 weeks

    Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.

  9. Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.

    Time frame: 4 weeks

  10. Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 2 weeks.

    Time frame: 2 weeks

  11. Change from 2 weeks in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.

    Time frame: Between 2 and 4 weeks

  12. Change from Baseline in the phenol and p-Cresol in the feces at 4 weeks.

    Time frame: 4 weeks

  13. Change from Baseline in the phenol and p-Cresol in the feces at 2 weeks.

    Time frame: 2 weeks

  14. Change from 2 weeks in the phenol and p-Cresol in the feces at 4 weeks.

    Time frame: Between 2 and 4 weeks

  15. Change from Baseline in the faecal pH and dry matter at 4 weeks.

    Time frame: 4 weeks

  16. Change from Baseline in the faecal pH and dry matter at 2 weeks.

    Time frame: 2 weeks

  17. Change from 2 weeks in the faecal pH and dry matter at 4 weeks.

    Time frame: Between 2 and 4 weeks

  18. Change from Baseline in secretory Immunoglobulin A (IgA) at 4 weeks.

    Time frame: 4 weeks

    Measured with s-IgA ELISA kit.

  19. Change from Baseline in secretory Immunoglobulin A (IgA) at 2 weeks.

    Time frame: 2 weeks

    Measured with s-IgA ELISA kit.

  20. Change from 2 weeks in secretory Immunoglobulin A (IgA) at 4 weeks.

    Time frame: Between 2 and 4 weeks

    Measured with s-IgA ELISA kit.

  21. Change from Baseline in cytokines at 4 weeks

    Time frame: 4 weeks

    Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10

  22. Change from Baseline in cytokines at 2 weeks

    Time frame: 2 weeks

    Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10

  23. Change from 2 weeks in cytokines at 4 weeks

    Time frame: Between 2 and 4 weeks

    Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10

  24. Change from Baseline in dietary intakes at 4 weeks

    Time frame: 4 weeks

    Data extracted from a 3-day food diary.

  25. Change from Baseline in dietary intakes at 2 weeks

    Time frame: 2 weeks

    Data extracted from a 3-day food diary.

  26. Change from 2 weeks in dietary intakes at 4 weeks

    Time frame: Between 2 and 4 weeks

    Data extracted from a 3-day food diary.

  27. Change from Baseline of circulating lipopolysaccharides (LPS) at 4 weeks.

    Time frame: 4 weeks

    Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.

  28. Change from Baseline of circulating lipopolysaccharides (LPS) at 2 weeks.

    Time frame: 2 weeks

    Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.

  29. Change from 2 weeks of circulating lipopolysaccharides (LPS) at 4 weeks.

    Time frame: Between 2 and 4 weeks

    Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.

  30. Change from Baseline in the subjects' tolerance to the test products at 4 weeks.

    Time frame: 4 weeks

    Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm).Stool frequency (stool per day).

  31. Change from Baseline in the subjects' tolerance to the test products at 2 weeks.

    Time frame: 2 weeks

    Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm). Stool frequency (stool per day).

  32. Change from 2 weeks in the subjects' tolerance to the test products at 4 weeks.

    Time frame: Between 2 and 4 weeks

    Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm). Stool frequency (stool per day).

Other outcomes

  1. Change from Selection (at least 2 weeks before Baseline) in Weight, Height, BMI, Blood pressure, Heart rate at 4 weeks

    Time frame: 4weeks

  2. Change from Selection (at least 2 weeks before Baseline) in Weight, Height, BMI, Blood pressure, Heart rate at 2 weeks

    Time frame: 2 weeks

  3. Change from 2 weeks in Weight, Height, BMI, Blood pressure, Heart rate at 4 weeks

    Time frame: Between 2 and 4 weeks

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Lille

Other

Collaborators

  • Institut Polytechnique LaSalle Beauvais

Registry information

Official study 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

Acronym: PIB

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 11, 2014
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.