Fenugreek: an Emergent Allergen

NCT06257797 | Completed

• 1 other identifier: 3/24
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Fenugreek or Trigonella foenum greacum is an ancient medicinal plant native to the eastern Mediterranean, later spread to Asia (especially in India); it belongs to Rosaceae order, Leguminosae family, subfamily of Papilonaceae and it is used as a medicinal herb, spice or food. It is a component of spice mix, such as curry, and it is also used as a supplement in wheat and corn flour for bread-making. Fenugreek appears to have many health benefits and potential medicinal properties (antioxidant, antidiabetic, hepatoprotective, hypocholesterolemic, antimicrobial, anti-inflammatory, neuroprotective, anticarcinogenic, antiulcer, and antilithigenic) both in vitro and in vivo studies; for this reason it may be increasingly being used as nutraceutical formulations (powder, herbal teas, tablets and various combinations).This study aims to describe patients who came to our operating unit for suspected adverse reaction after ingestion of fenugreek and to highlight possible cross-reactivity between fenugreek and other legumes or other foods. Given the increasing use of novel spices in Mediterranean cuisine and the possible spread of fenugreek-based nutraceuticals, it is relevant to draw attention to possible allergic reactions.

Conditions

Fenugreek Hypersensitivity - Cross-reactivity - Food Allergy

Outcome Measures

Primary Outcomes (1)

• Cutaneous sensitization to fenugreek

  Cutaneous sensitization to fenugreek evaluated by the result of skin prick test in patients with suggestive history of allergic reactions to spices.

  1 hour

Secondary Outcomes (1)

• Cross-reactivity between fenugreek and other legumes and other foods

  1 hour

Study Arms (2)

Allergic patients to fenugreek

Diagnostic Test: Skin prick test

Non allergic patients to fenugreek

Diagnostic Test: Skin prick test

Interventions

Skin prick test DIAGNOSTIC_TEST

Fenugreek wiil be tested by mixing fenugreek seed powder with saline at non-irritating doses and it will be performed by prick-by-prick test. The skin tests will be read 20 minutes after the execution.

Allergic patients to fenugreek; Non allergic patients to fenugreek

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred to outpatients visit to the Operative Unit of Allergy and Clinical Immunology of Messina University Hospital with a suggestive history of allergy after ingestion of spices and tested for fenugreek.

You may qualify if:

• age \> 18 yo
• history of allergic reactions to spices
• history of allergic reactions to phytotherapics containing fenugreek

You may not qualify if:

• age \< 18 yo
• non suggestive history of allergic reactions to spices

Sponsors & Collaborators

• Paola Miciullo: lead

Study Sites (1)

AOU Policlinico Universitario G. Martino

Messina, Sicily/Messina, 98124, Italy

Location

MeSH Terms

Interventions

Patch Tests

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 14, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

IT (1)