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Completed

NCT Number: NCT03505177

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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, 1348, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Chitin-glucan fiber

Dietary Supplement

4.5g per day of chitin-glucan during 3 weeks

Primary outcomes

  1. Gut microbiota composition

    Time frame: Difference between day 0 and day 21

    Illumina sequencing of 16SrDNA

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Nathalie Delzenne

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 23, 2018
Registry last updated
May 23, 2018

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.

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