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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Artisanal Bread

    Dietary supplement

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Artisanal BreadExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Scores at Day 0 [D0] and Day 15 [D15]

Secondary outcomes

1

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.

Time frame
Scores at Day 0 [D0] and Day 15 [D15]
2

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.

Time frame
Scores of the two questionnaires at Day [D0] and Day [D15]
3

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.

Time frame
Scores at Day 0 [D0] and Day 15 [D15]
4

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.

Time frame
These scores are measured at Day 0 [D0], Day 8 [D8] and Day 15 [D15].

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

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

Collaborator