RecruitingNot ApplicableNCT07568223

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


Sponsor

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

Enrollment

40 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • Normal weight (18 < BMI < 25 kg.m-2)
  • Male or female
  • to 65 years old
  • Adults reporting intolerance to "conventional" bread
  • Absence of celiac disease
  • Affiliated to a social security scheme
  • Free, informed and express consent

Exclusion Criteria9

  • People under protective supervision: legal guardianship, tutorship or curatorship
  • People with eating disorders (anorexia, bulimia, binge eating)
  • Any known food allergy
  • Women who are pregnant or potentially pregnant (based on a positive urine pregnancy test at inclusion)
  • Breastfeeding women
  • Alcohol abuse (>2 drinks/day). At the time of inclusion, the investigator will assess whether the participant exhibits harmful alcohol consumption
  • Untreated hypertension, uncontrolled diabetes, or diseases of the digestive tract (excluding functional intestinal disorders), liver, kidneys, or severe heart disease. The investigator will assess the presence of these conditions on standard clinical criteria and the participants' self-reported medical history at the time of inclusion
  • Participation in a clinical study in the three months preceding the study
  • Absence of express consent

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Interventions

DIETARY_SUPPLEMENTArtisanal Bread

During the second part of the study (from Day 1 \[D1\] to Day 14 \[D14\]), participants will consume the "artisanal" bread on a daily basis. Dose: D1 = 75g; D2 = 100g; from D3 to D14: 125g/day On D0 and D15, volunteers will come to the hospital for 3 hours of postprandial testing.


Locations(2)

Centre de Recherche sur Volontaires

Bobigny, France

Centre de Recherche sur Volontaires (CRV)

Bobigny, Île-de-France Region, France

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NCT07568223