NCT03773900

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

November 16, 2018

Last Update Submit

September 9, 2025

Conditions

Cardiometabolic RiskAbdominal Obesity

Keywords

chitin-glucangut microbiotaFecal Short Chain Fatty Acid (SCFA)cardiometabolic risknutritional challenge testbiomarkers

Outcome Measures

Primary Outcomes (1)

  • Fecal SCFA

    Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector

    baseline and three weeks

Secondary Outcomes (20)

  • gut microbiota composition

    baseline and three weeks

  • fecal biliary acids

    baseline and three weeks

  • fecal PolyUnsaturated Fatty Acids (PUFA)

    baseline and three weeks

  • fecal albumin

    baseline and three weeks

  • fecal zonulin

    baseline and three weeks

  • +15 more secondary outcomes

Study Arms (2)

Chitin-Glucan supplementation

EXPERIMENTAL
Dietary Supplement: Kiotransine (chitin-glucan from aspergillus niger)

Placebo supplementation

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

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.

Chitin-Glucan supplementation
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.

Placebo supplementation

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pierre-Bénite, 69310, France

Location

Related Publications (1)

  • 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.

    PMID: 35614185BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

December 12, 2018

Study Start

November 7, 2018

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)