HealthyNCT03505177
Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation
A study testing Chitin-glucan fiber in people with Healthy, run by Nathalie Delzenne at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Chitin-glucan fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Apr 2018to 18 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center of Investigation in Clinical Nutrition
Louvain-la-Neuve, 1348
About this study
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.
- Conditions
- Healthy
- Being tested
- Chitin-glucan fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitin-glucan fiberDietary supplement
4.5g per day of chitin-glucan during 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Chitin-glucan | Experimental | Supplementation during 3 weeks with 4.5g per day of chitin-glucan fiber Receives: Dietary Supplement: Chitin-glucan fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition
Illumina sequencing of 16SrDNA
Measured: Difference between day 0 and day 21
Secondary outcomes (31)
Fecal short-chain fatty acids
Gas chromatography using Flame ionization detector (GC- FID)
Measured: Difference between day 0 and day 21
Fecal bile acids
Gas chromatography-mass spectrometry (GC/MS)
Measured: Difference between day 0 and day 21
Fecal conjugated-linoleic acids
Gas chromatography using Flame ionization detector (GC- FID)
Measured: Difference between day 0 and day 21
Exhaled acetate
Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled propionate
Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled butyrate
Gas chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled C2
Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled CO2
Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled H2S
Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled O2
Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled N2
Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled CH4
Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled CO
Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled H2
Gas chromatography using Thermal Conductivity Detector (GC-TCD) - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Exhaled volatile compounds
Gas chromatography using selected ion flow tube mass spectrometry - Area under the curve (calculated on 10 hours following high-fiber test meal ingestion)
Measured: Difference between day 0 and day 21
Gastro-intestinal symptom - discomfort
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation
Measured: 3 weeks
Gastro-intestinal symptom - nausea
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation
Measured: 3 weeks
Gastro-intestinal symptom - bloating
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation
Measured: 3 weeks
Gastro-intestinal symptom - flatulences
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation
Measured: 3 weeks
Gastro-intestinal symptom - gastrointestinal reflux
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation
Measured: 3 weeks
Gastro-intestinal symptom - cramps
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation
Measured: 3 weeks
Gastro-intestinal symptom - rumbling
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation
Measured: 3 weeks
Gastro-intestinal symptom - burps
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - every day during the chitin-glucan supplementation
Measured: 3 weeks
Gastro-intestinal symptom - discomfort
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)
Measured: Difference between Day 0 and Day 21
Gastro-intestinal symptom - nausea
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)
Measured: Difference between Day 0 and Day 21
Gastro-intestinal symptom - bloating
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)
Measured: Difference between Day 0 and Day 21
Gastro-intestinal symptom - flatulences
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)
Measured: Difference between Day 0 and Day 21
Gastro-intestinal symptom - gastrointestinal reflux
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)
Measured: Difference between Day 0 and Day 21
Gastro-intestinal symptom - cramps
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)
Measured: Difference between Day 0 and Day 21
Gastro-intestinal symptom - rumbling
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)
Measured: Difference between Day 0 and Day 21
Gastro-intestinal symptom - burps
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)
Measured: Difference between Day 0 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start22 Apr 2018
- Primary completion18 May 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Supplementation during 3 weeks with 4.5g of chitin-glucan
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathalie Delzenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nathalie Delzenne, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505177
- Sponsor's protocol ID
- FiberTAG2
- Status last verified
- May 2018
- First submitted
- 12 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation
- ClinicalTrials.gov ID
- NCT03505177
- Acronym / sponsor ID
- FiberTAG2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nathalie DelzenneUniversity, hospital or other
- Study start
- 22 Apr 2018 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Supplementation during 3 weeks with 4.5g of chitin-glucan
| Arm | Type | Receives |
|---|---|---|
| Chitin-glucan | Experimental | Dietary Supplement: Chitin-glucan fiberSupplementation during 3 weeks with 4.5g per day of chitin-glucan fiber |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitin-glucan fiber4.5g per day of chitin-glucan during 3 weeks | Dietary supplement | Chitin-glucan |
Primary outcome
Gut microbiota composition
Time frame: Difference between day 0 and day 21
Illumina sequencing of 16SrDNA
31 secondary outcomes
Fecal short-chain fatty acids
Time frame: Difference between day 0 and day 21
Fecal bile acids
Time frame: Difference between day 0 and day 21
Fecal conjugated-linoleic acids
Time frame: Difference between day 0 and day 21
Exhaled acetate
Time frame: Difference between day 0 and day 21
Exhaled propionate
Time frame: Difference between day 0 and day 21
Exhaled butyrate
Time frame: Difference between day 0 and day 21
Exhaled C2
Time frame: Difference between day 0 and day 21
Exhaled CO2
Time frame: Difference between day 0 and day 21
Exhaled H2S
Time frame: Difference between day 0 and day 21
Exhaled O2
Time frame: Difference between day 0 and day 21
Exhaled N2
Time frame: Difference between day 0 and day 21
Exhaled CH4
Time frame: Difference between day 0 and day 21
Exhaled CO
Time frame: Difference between day 0 and day 21
Exhaled H2
Time frame: Difference between day 0 and day 21
Exhaled volatile compounds
Time frame: Difference between day 0 and day 21
Gastro-intestinal symptom - discomfort
Time frame: 3 weeks
Gastro-intestinal symptom - nausea
Time frame: 3 weeks
Gastro-intestinal symptom - bloating
Time frame: 3 weeks
Gastro-intestinal symptom - flatulences
Time frame: 3 weeks
Gastro-intestinal symptom - gastrointestinal reflux
Time frame: 3 weeks
Gastro-intestinal symptom - cramps
Time frame: 3 weeks
Gastro-intestinal symptom - rumbling
Time frame: 3 weeks
Gastro-intestinal symptom - burps
Time frame: 3 weeks
Gastro-intestinal symptom - discomfort
Time frame: Difference between Day 0 and Day 21
Gastro-intestinal symptom - nausea
Time frame: Difference between Day 0 and Day 21
Gastro-intestinal symptom - bloating
Time frame: Difference between Day 0 and Day 21
Gastro-intestinal symptom - flatulences
Time frame: Difference between Day 0 and Day 21
Gastro-intestinal symptom - gastrointestinal reflux
Time frame: Difference between Day 0 and Day 21
Gastro-intestinal symptom - cramps
Time frame: Difference between Day 0 and Day 21
Gastro-intestinal symptom - rumbling
Time frame: Difference between Day 0 and Day 21
Gastro-intestinal symptom - burps
Time frame: Difference between Day 0 and Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitin-glucan fiber in people with Healthy, run by Nathalie Delzenne at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition (time frame: Difference between day 0 and day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.