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Completed

NCT Number: NCT03494491

Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration

The aim of this research study is to characterize the fermentation of chitin-glucan fiber by assessing the volatile compounds released in the breath. For this purpose, an interventional study with control will be performed. After a single administration of 4.5 g of chitin-glucan fiber, the kinetic of production of exhaled volatile compounds (such as H2, methane, SCFAs,…) will be measured during twelve hours. These results will be compared to the exhaled volatile compounds measured during twelve hours after supplementation with 4.5g of maltodextrin (placebo).

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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
  • For women: use of highly effective contraception
  • H2 - producer as evidenced by the screening test (described in latter section)
  • 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 antibiotics, probiotics, prebiotics, fiber supplement, and/or any products 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 1 month before the screening test visit
  • Subjects presenting an allergy or intolerance to one component of the product tested

Treatment and study plan

Chitin-glucan

Dietary Supplement

Second test day (D2), subjects will received 4.5g of chitine-glucan

Maltodextrin

Dietary Supplement

First test day (D0), subjects will received 4.5g of maltodextrin.

Primary outcomes

  1. Exhaled acetate

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  2. Exhaled propionate

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  3. Exhaled butyrate

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

Secondary outcomes

  1. Gut microbiota

    Time frame: within 4 days before the second test day

    Illumina sequencing of 16SrDNA and GC-FID

  2. Fecal short-chain fatty acids

    Time frame: Within 4 days before the ingestion of chitin-glucan

    Gaz chromatography using Flame ionization detector (GC- FID)

  3. Fecal conjugated-linoleic acids

    Time frame: Within 4 days before the ingestion of chitin-glucan

    Gaz chromatography using Flame ionization detector (GC- FID)

  4. Fecal bile acids

    Time frame: Within 4 days before the ingestion of chitin-glucan

    Gas chromatography-mass spectrometry (GC/MS)

  5. Gastro-intestinal symptom - discomfort

    Time frame: Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  6. Gastro-intestinal symptom - nausea

    Time frame: Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  7. Gastro-intestinal symptom - bloating

    Time frame: Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  8. Gastro-intestinal symptom - flatulences

    Time frame: Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  9. Gastro-intestinal symptom - gastrointestinal reflux

    Time frame: Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  10. Gastro-intestinal symptom - cramps

    Time frame: Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  11. Gastro-intestinal symptom - rumbling

    Time frame: Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  12. Gastro-intestinal symptom - burps

    Time frame: Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion

    100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  13. Exhaled C2

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  14. Exhaled CO2

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  15. Exhaled H2S

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  16. Exhaled O2

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  17. Exhaled N2

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  18. Exhaled CH4

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  19. Exhaled CO

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  20. Exhaled H2

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

  21. Exhaled volatils compounds (for other short-chain fatty acids and other volatile organic compounds)

    Time frame: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion

    Gaz chromatography using selected ion flow tube mass spectrometry - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2018
Registry last updated
Apr 11, 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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