Cardiometabolic RiskFITACHITINNCT03773900
Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers
A study testing Kiotransine (chitin-glucan from aspergillus niger) in people with Cardiometabolic Risk and Abdominal Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of this study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for three weeks. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk, Abdominal Obesity
- What is being tested?
- Kiotransine (chitin-glucan from aspergillus niger)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2018to 6 Jun 2019
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Non-smokers
- Body mass index between 25 and 35 kg/m2
- Waist circumference < 80cm for women and > 94 cm for men
- Fiber intake <25g/day
Who cannot join
- Medical history of digestive surgery or disease
- Current or recent (<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
- Current probiotics, prebiotics, fiber complement, and/or any products modulation gut transit
- Feeding particular diet such as vegetarian diet or hyperprotein diet
- Current weight loss diet
- Pregnant or lactating woman or woman who did not use effective contraception
- Drinking more than 3 glasses of alcohol per day (>30g/day)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud
Pierre-Bénite, 69310
About this study
The aim of this study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for three weeks. The first studies about the fiber have shown a favorable gut microbiota modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases, PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15 grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber intake and the intestinal transit modification will be also followed during all the study.
- Conditions
- Cardiometabolic Risk, Abdominal Obesity
- Being tested
- Kiotransine (chitin-glucan from aspergillus niger), Placebo
- Keywords
- chitin-glucan, gut microbiota, Fecal Short Chain Fatty Acid (SCFA), cardiometabolic risk, nutritional challenge test, biomarkers
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kiotransine (chitin-glucan from aspergillus niger)Dietary supplement
The volunteers will take three times a day one bag of powder containing 1.5g of chitin-glucan fiber during three weeks. The powder will be diluted in water.
PlaceboDietary supplement
The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.
| Study group | Role | What they receive |
|---|---|---|
| Chitin-Glucan supplementation | Experimental | Not described Receives: Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger) |
| Placebo supplementation | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal SCFA
Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector
Measured: baseline and three weeks
Secondary outcomes (20)
gut microbiota composition
Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing
Measured: baseline and three weeks
fecal biliary acids
Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)
Measured: baseline and three weeks
fecal PolyUnsaturated Fatty Acids (PUFA)
Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)
Measured: baseline and three weeks
fecal albumin
Change from baseline fecal albumin by immunoenzymatic technique (ELISA)
Measured: baseline and three weeks
fecal zonulin
Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)
Measured: baseline and three weeks
fecal calprotectin
Change from baseline fecal calprotectin by Phadia 100 system
Measured: baseline and three weeks
TLR-agonist in stool
Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules
Measured: baseline and three weeks
Change from baseline CO2, CH4 and H2 kinetics in exhaled gases
by gas chromatography, during ten hours after rich-fiber breakfast and nutritional challenge test at lunch
Measured: baseline and three weeks
body composition
Change from baseline bodycompositio by bioimpedancemetry
Measured: baseline and three weeks
Change from plasma glucose kinetics
by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Measured: baseline and three weeks
Change from plasma insulin kinetics
by radio-immuno analysis , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Measured: baseline and three weeks
Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics
by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Measured: baseline and three weeks
plasma TriacylGlycerol (TG) kinetics
Change from plasma TriacylGlycerol (TG) kinetics by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
Measured: baseline and three weeks
Cholesterol Total, Cholesterol LDL
Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method
Measured: baseline and three weeks
resting energy expenditure
Change from baseline resting energy expenditure by indirect calorimetry
Measured: baseline and three weeks
stool consistency
by Bristol Stool Chart (type1-7)
Measured: every week, up to three weeks
stool frequency
by questionnaire
Measured: every week, up to three weeks
gastro-intestinal symptoms
by questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum))
Measured: every week, up to three weeks
quality of life during the study
change from baseline quality of life during the study by SF 36 questionnaire
Measured: baseline and three weeks
change from baseline dietary intake of fibre
by three day food record
Measured: baseline and three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start7 Nov 2018
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773900
- Sponsor's protocol ID
- 69HCL18_0362
- Acronym
- FITACHITIN
- Status last verified
- Sep 2025
- First submitted
- 16 Nov 2018
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ranaivo H, Zhang Z, Alligier M, Van Den Berghe L, Sothier M, Lambert-Porcheron S, Feugier N, Cuerq C, Machon C, Neyrinck AM, Seethaler B, Rodriguez J, Roumain M, Muccioli GG, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM, Nazare JA. Chitin-glucan supplementation improved postprandial metabolism and altered gut microbiota in subjects at cardiometabolic risk in a randomized trial. Sci Rep. 2022 May 25;12(1):8830. doi: 10.1038/s41598-022-12920-z.
PubMed 35614185
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers
- ClinicalTrials.gov ID
- NCT03773900
- Acronym / sponsor ID
- FITACHITIN / 69HCL18_0362
- Conditions
- Cardiometabolic Risk, Abdominal Obesity
- Keywords
- chitin-glucan, gut microbiota, Fecal Short Chain Fatty Acid (SCFA), cardiometabolic risk, nutritional challenge test, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 12 Dec 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 study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for three weeks. The first studies about the fiber have shown a favorable gut microbiota modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases, PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15 grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber intake and the intestinal transit modification will be also followed during all the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chitin-Glucan supplementation | Experimental | Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger) |
| Placebo supplementation | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- Non-smokers
- Body mass index between 25 and 35 kg/m2
- Waist circumference < 80cm for women and > 94 cm for men
- Fiber intake <25g/day
Key exclusion criteria (7 listed)
- Medical history of digestive surgery or disease
- Current or recent (<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
- Current probiotics, prebiotics, fiber complement, and/or any products modulation gut transit
- Feeding particular diet such as vegetarian diet or hyperprotein diet
- Current weight loss 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 |
|---|---|---|
| Kiotransine (chitin-glucan from aspergillus niger)The volunteers will take three times a day one bag of powder containing 1.5g of chitin-glucan fiber during three weeks. The powder will be diluted in water. | Dietary supplement | Chitin-Glucan supplementation |
| PlaceboThe volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water. | Dietary supplement | Placebo supplementation |
Primary outcome
Fecal SCFA
Time frame: baseline and three weeks
Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector
20 secondary outcomes
gut microbiota composition
Time frame: baseline and three weeks
fecal biliary acids
Time frame: baseline and three weeks
fecal PolyUnsaturated Fatty Acids (PUFA)
Time frame: baseline and three weeks
fecal albumin
Time frame: baseline and three weeks
fecal zonulin
Time frame: baseline and three weeks
fecal calprotectin
Time frame: baseline and three weeks
TLR-agonist in stool
Time frame: baseline and three weeks
Change from baseline CO2, CH4 and H2 kinetics in exhaled gases
Time frame: baseline and three weeks
body composition
Time frame: baseline and three weeks
Change from plasma glucose kinetics
Time frame: baseline and three weeks
Change from plasma insulin kinetics
Time frame: baseline and three weeks
Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics
Time frame: baseline and three weeks
plasma TriacylGlycerol (TG) kinetics
Time frame: baseline and three weeks
Cholesterol Total, Cholesterol LDL
Time frame: baseline and three weeks
resting energy expenditure
Time frame: baseline and three weeks
stool consistency
Time frame: every week, up to three weeks
stool frequency
Time frame: every week, up to three weeks
gastro-intestinal symptoms
Time frame: every week, up to three weeks
quality of life during the study
Time frame: baseline and three weeks
change from baseline dietary intake of fibre
Time frame: baseline and three weeks
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 15 Sep 2025.
- Results publication: PubMed 35614185Ranaivo H, Zhang Z, Alligier M, Van Den Berghe L, Sothier M, Lambert-Porcheron S, Feugier N, Cuerq C, Machon C, Neyrinck AM, Seethaler B, Rodriguez J, Roumain M, Muccioli GG, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM, Nazare JA. Chitin-glucan supplementation improved postprandial metabolism and altered gut microbiota in subjects at cardiometabolic risk in a randomized trial. Sci Rep. 2022 May 25;12(1):8830. doi: 10.1038/s41598-022-12920-z.
- Related InfoLink provided by the sponsor.
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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 Kiotransine (chitin-glucan from aspergillus niger) in people with Cardiometabolic Risk and Abdominal Obesity, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 7 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 15 Sep 2025. 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 France. 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. Some participants in this study may receive a placebo. 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?
Fecal SCFA (time frame: baseline and three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773900, which also lists 1 linked publication.
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 15 Sep 2025.