Artisanal 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Normal weight (18 \< BMI \< 25 kg.m-2)
* Male or female
* 18 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 Criteria:
* 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
Primary outcome measure(s)
Intensity of gastrointestinal symptoms — Scores at Day 0 [D0] and Day 15 [D15] The severity of gastrointestinal symptoms will be assessed using a score from the modified GSRS-IBS questionnaire used in this study.
This score consists of 13 questions ranging from 1 (Not at all) to 7 (Very severely) on a Likert scale. Thus, the total score can range from 13 to 91, with higher scores indicating more severe gastrointestinal symptoms and, consequently, lower tolerance.
The scores obtained before and after the diet including the "artisanal" bread will be compared.
Trial sites (2)
Facility
City
Region
Status
Centre de Recherche sur Volontaires
Bobigny
France
Recruiting
Centre de Recherche sur Volontaires (CRV)
Bobigny
Île-de-France Region
Not Yet Recruiting
More Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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