Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07568223

Tolerance to an Artisanal Bread in a Population Intolerant of the Conventional Bread and Study of Associated Markers

Led by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Updated on 2026-05-05

40

Participants Needed

2

Research Sites

69 weeks

Total Duration

On this page

Sponsors

I

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Lead Sponsor

U

UMR 914 PNCA - AgroParisTech, INRA, Université Paris-Saclay

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objective of this study is to evaluate the effect of consuming an "artisanal" bread for 15 days on gastrointestinal symptoms in individuals intolerant to "conventional" bread. "Conventional bread" refers to bread made with refined wheat flour (ash = 0.55% of dry matter), containing gluten, and leavened with baker's yeast (Saccharomyces cerevisiae). "Artisanal bread" refers to bread made with whole wheat flour (ash = 1.50% of dry matter) from an ancient durum wheat variety (Russello) and leavened with sourdough.

CONDITIONS

Official Title

Tolerance to an Artisanal Bread in a Population Intolerant of the Conventional Bread and Study of Associated Markers

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Normal weight (BMI between 18 and 25 kg/m²)
  • Male or female
  • Age between 18 and 65 years
  • Adults reporting intolerance to conventional bread
  • No diagnosis of celiac disease
  • Affiliated with a social security scheme
  • Provided free, informed, and express consent
Not Eligible

You will not qualify if you...

  • Under legal guardianship, tutorship, or curatorship
  • Diagnosis of eating disorders such as anorexia, bulimia, or binge eating
  • Known food allergies
  • Pregnant or potentially pregnant women
  • Breastfeeding women
  • Alcohol abuse exceeding 2 drinks per day
  • Untreated hypertension, uncontrolled diabetes, or diseases affecting the digestive tract (excluding functional disorders), liver, kidneys, or severe heart disease
  • Participation in another clinical study within the last three months
  • Absence of express consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centre de Recherche sur Volontaires

Bobigny, France, 93000

Actively Recruiting

2

Centre de Recherche sur Volontaires (CRV)

Bobigny, Île-de-France Region, France, 93000

Not Yet Recruiting

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Research Team

F

Fabien Wuestenberghs

CONTACT

C

Claire Gaudichon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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