About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Normal weight (18 < BMI < 25 kg.m-2)
Male or female
18 to 65 years old
Adults reporting intolerance to "conventional" bread
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Artisanal Bread
Dietary supplementDuring 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.
Treatment groups
Trial outcomes
Primary outcomes
Intensity of gastrointestinal symptoms
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.
Secondary outcomes
Intensity of gastrointestinal and extraintestinal symptoms
The intensity of gastrointestinal and extra-intestinal symptoms will be assessed using the total score of the modified version of the GSRS-IBS questionnaire. Scores obtained before and after the diet including the "artisanal" bread will be compared. The score is measured on a 7-point Likert scale, ranging from 1 (Not at all) to 7 (Very severely). The questionnaire consists of 28 questions, so total scores can range from 28 to 196, with higher scores indicating more severe gastrointestinal and extra-intestinal symptoms and, therefore, lower tolerance.
Validity of the modified GSRS-IBS
Correlations between the scores from the GSRS-IBS and the modified GSRS-IBS used in this study will be analyzed. The GSRS-IBS score can be obtained from the modified GSRS-IBS questionnaire. This questionnaire consists of 7-point Likert scale ranging from 1 (No discomfort at all) to 7 (Very severe discomfort) for 13 items. The total score therefore ranges from 13 to 91. An increase in this score indicates greater gastrointestinal discomfort and, consequently, lower tolerance. The modified GSRS-IBS questionnaire comprises 28 items scored on a 7-point Likert scale, ranging from 1 (Not at all) to 7 (Very severely). Thus, the total score of this questionnaire ranges from 28 to 196. An increase in this score indicates greater gastrointestinal symptoms and, consequently, lower tolerance. These two scores will be compared, and their correlation analyzed.
Comparison between volunteers' perceived tolerance of "artisanal" bread and measured tolerance
In addition to the intensity scores calculated for each symptom (the sum of which constitutes an objective total score), participants will give a global subjective assessment of their tolerance to the "artisanal" bread using a scale from 0 (absence of symptoms) to 10 (extremely intense symptoms). The objective and subjective scores will then be compared, and their correlation analyzed.
Clinical profile of response to the "artisanal" bread
Individual symptoms will be grouped into symptom groups (pain, reflux, indigestion, diarrhea and constipation). A score will be calculated for each groupe, and these scores will be compared.
Sponsors and contacts
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Lead sponsor
UMR 914 PNCA - AgroParisTech, INRA, Université Paris-Saclay
Collaborator