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Trial record 22 of 29 for:    GUSB

Prebiotics Change Microflora and Decrease LPS (PIB)

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ClinicalTrials.gov Identifier: NCT02287844
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : November 17, 2014
Sponsor:
Collaborator:
Institut Polytechnique LaSalle Beauvais
Information provided by (Responsible Party):
Jean-Michel Lecerf, Institut Pasteur de Lille

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.

Condition or disease Intervention/treatment Phase
Prebiotics Effect Other: XOS Other: INU-XOS Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Start Date : October 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287844


Locations
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France
Institut Polytechnique LaSalle Beauvais
Beauvais, Oise, France, 60000
Sponsors and Collaborators
Institut Pasteur de Lille
Institut Polytechnique LaSalle Beauvais

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Responsible Party: Jean-Michel Lecerf, MD, Nutritionist, Institut Pasteur de Lille
ClinicalTrials.gov Identifier: NCT02287844     History of Changes
Other Study ID Numbers: 2007-A00273-50
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014
Keywords provided by Jean-Michel Lecerf, Institut Pasteur de Lille:
Xylo-oligosaccharides
Immunonutrition
Prebiotics
Lipopolysaccharides
Cytokines