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Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation

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ClinicalTrials.gov Identifier: NCT03505177
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Nathalie Delzenne, Université Catholique de Louvain

Brief Summary:
The aim of this research study is to characterize gut microbiota composition and activity after a daily supplementation of 4.5 g of chitin-glucan during 3 weeks. For this purpose, a monocentric longitudinal intervention study without control will be performed. Fecal microbiota composition and fecal concentrations of gut microbiota-derived metabolites (bile acids, conjugated-polyunsaturated fatty acids and short-chain fatty acids) will be measured. In addition, during ten hours following the ingestion of a test meal rich in fibers, the kinetic of production of H2, methane and volatile compounds exhaled from breath will be evaluated.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Chitin-glucan fiber Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Supplementation during 3 weeks with 4.5g of chitin-glucan
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation
Actual Study Start Date : April 22, 2018
Actual Primary Completion Date : May 18, 2018
Actual Study Completion Date : May 18, 2018

Arm Intervention/treatment
Experimental: Chitin-glucan
Supplementation during 3 weeks with 4.5g per day of chitin-glucan fiber
Dietary Supplement: Chitin-glucan fiber
4.5g per day of chitin-glucan during 3 weeks




Primary Outcome Measures :
  1. Gut microbiota composition [ Time Frame: Difference between day 0 and day 21 ]
    Illumina sequencing of 16SrDNA


Secondary Outcome Measures :
  1. Fecal short-chain fatty acids [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Flame ionization detector (GC- FID)

  2. Fecal bile acids [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography-mass spectrometry (GC/MS)

  3. Fecal conjugated-linoleic acids [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Flame ionization detector (GC- FID)

  4. Exhaled acetate [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  5. Exhaled propionate [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  6. Exhaled butyrate [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  7. Exhaled C2 [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  8. Exhaled CO2 [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  9. Exhaled H2S [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  10. Exhaled O2 [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  11. Exhaled N2 [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  12. Exhaled CH4 [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  13. Exhaled CO [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  14. Exhaled H2 [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  15. Exhaled volatile compounds [ Time Frame: Difference between day 0 and day 21 ]
    Gas chromatography using selected ion flow tube mass spectrometry - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  16. Gastro-intestinal symptom - discomfort [ Time Frame: 3 weeks ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation

  17. Gastro-intestinal symptom - nausea [ Time Frame: 3 weeks ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation

  18. Gastro-intestinal symptom - bloating [ Time Frame: 3 weeks ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation

  19. Gastro-intestinal symptom - flatulences [ Time Frame: 3 weeks ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation

  20. Gastro-intestinal symptom - gastrointestinal reflux [ Time Frame: 3 weeks ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation

  21. Gastro-intestinal symptom - cramps [ Time Frame: 3 weeks ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation

  22. Gastro-intestinal symptom - rumbling [ Time Frame: 3 weeks ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation

  23. Gastro-intestinal symptom - burps [ Time Frame: 3 weeks ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation

  24. Gastro-intestinal symptom - discomfort [ Time Frame: Difference between Day 0 and Day 21 ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  25. Gastro-intestinal symptom - nausea [ Time Frame: Difference between Day 0 and Day 21 ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  26. Gastro-intestinal symptom - bloating [ Time Frame: Difference between Day 0 and Day 21 ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  27. Gastro-intestinal symptom - flatulences [ Time Frame: Difference between Day 0 and Day 21 ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  28. Gastro-intestinal symptom - gastrointestinal reflux [ Time Frame: Difference between Day 0 and Day 21 ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  29. Gastro-intestinal symptom - cramps [ Time Frame: Difference between Day 0 and Day 21 ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  30. Gastro-intestinal symptom - rumbling [ Time Frame: Difference between Day 0 and Day 21 ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)

  31. Gastro-intestinal symptom - burps [ Time Frame: Difference between Day 0 and Day 21 ]
    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Woman or man, aged of 18 to 40 years
  • Body mass index (BMI) between 18 and 25 kg/m2
  • In good general health as evidenced by medical history and physical examination
  • Non-smoker
  • Caucasian
  • H2 - producer
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

  • Subjects presenting gastro-intestinal disorders such as ulcers, diverticulitis and inflammatory bowel diseases
  • Subject presenting allergy or food intolerance (lactose, gluten,…)
  • Subjects with psychiatric problems and/or using antipsychotics
  • Current or recent (< 4 weeks) intake of antibiotic, probiotic, prebiotic, fiber supplement, and/or any product modulating gut transit
  • Feeding particular diet such as vegetarian diet or hyper protein diet
  • Chronic intake of drug, excepted contraceptive drug
  • Pregnant or lactating woman or woman who did not use highly effective contraception
  • Subjects who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day)
  • Subjects having participated to another clinical trial two weeks before the screening test visit
  • Subjects presenting an allergy or intolerance to one component of the product tested

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): NCT03505177


Locations
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Belgium
Center of Investigation in Clinical Nutrition
Louvain-la-Neuve, Belgium, 1348
Sponsors and Collaborators
Nathalie Delzenne

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Responsible Party: Nathalie Delzenne, Professor, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03505177     History of Changes
Other Study ID Numbers: FiberTAG2
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

All data will be shared by the partners from the Consortium agreement.

  • exhaled volatile metabolites
  • gut microbiota derived metabolites
  • visual analog scale data
  • concomitant medication, inclusion/exclusion criteria, adverse event, food and beverage consumption Data will be shared at the end of the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: At the end of the study
Access Criteria: Belonging to the project Consortium

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No