Prevalence of Sensitization to Legumes in a Region From Southern France (Légumineuses)

Not Applicable

Completed

• Conditions: Sensitization to Legumes
• Interventions: Other: Skin prick tests with four native legumes

• Registration Number: NCT03686891
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The Mediterranean diet is a model for health. Indeed, according to some epidemiological studies, it would participate in the prevention of various diseases such as cardiovascular diseases, diabetes type 2, cancer and obesity. Among the foods composing the Mediterranean diet, wheat and legumes are strongly represented. The introduction of legumes into an easily prepared and economical food for a large part of the population will lead to an increase in consumption. The combination of durum wheat semolina and legume flour would benefit from the nutritional qualities of the two raw materials (high protein, slow digestible carbohydrates, fiber, vitamins and minerals), but also of their double wheat-legume allergenicity.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-24
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-27
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients seen in allergy consultation
• The patient (or parents for the under 18 years) must have given their free consent and signed the consent chart
• Men and women are included
• The patient is at least 2 years old

Exclusion Criteria

• The patient is pregnant
• The patient is breast-feeding
• The patient is unable to stop in antihistamine medication for at least 7 days
• The patient refused or is unable to sign the consent chart
• The patient has a dermographism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Skin prick tests with four native legumes	Skin prick tests with four native legumes

Primary Outcome Measures

Name	Time	Method
Sensitization rate to four cooked legumes in the population consulting in Allergy Unit at the University Hospital of Montpellier	10 minutes (the average duration of the test will not be significantly increased)	A prick test will be considered as positive in the presence of a wheal of urticaria of at least 3 mm in size

Secondary Outcome Measures

Name	Time	Method
Describe the population with positive skin prick tests to legumes	5 years	A prick test will be considered as positive in the presence of a wheal of urticaria of at least 3 mm in size
Associations between symptoms on ingestion of these legumes	5 years	Association between the positivity of the legume prick test and (1) symptoms upon ingestion of legumes (e.g., aracid and other fruits and vegetables), (2) symptoms of rhinitis, asthma, atopic eczema, and (3) positivity to other prick tests of the standard pneumallergen battery

Trial Locations

Locations (1)

Service Exploration des allergologies-Hopital Arnaud de Villeneuve-CHU de Montpellier; 🇫🇷 Montpellier, France