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Completed

NCT Number: NCT03686891

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

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.

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Key information

Conditions

Sensitization to Legumes

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Exploration des allergologies-Hopital Arnaud de Villeneuve-CHU de Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin prick tests with four native legumes

Other

Skin prick tests with four native legumes

Primary outcomes

  1. Sensitization rate to four cooked legumes in the population consulting in Allergy Unit at the University Hospital of Montpellier

    Time frame: 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 outcomes

  1. Describe the population with positive skin prick tests to legumes

    Time frame: 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

  2. Associations between symptoms on ingestion of these legumes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Analyis of the Prevalence of Sensitization to Legumes by Realistic Skin Prick Tests in a Patient Population Consulting at the University Hospital of Montpellier

Acronym: Légumineuses

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2018
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.