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

NCT ID: NCT03773900

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2019-06-06

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiometabolic Risk Abdominal Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chitin-Glucan supplementation

Group Type EXPERIMENTAL

Kiotransine (chitin-glucan from aspergillus niger)

Intervention Type 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.

Placebo supplementation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 35614185 (View on PubMed)

Related Links

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Other Identifiers

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69HCL18_0362

Identifier Type: -

Identifier Source: org_study_id

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