Fenugreek: an Emergent Allergen

February 13, 2024 updated by: Paola Miciullo

Fenugreek: New Therapeutic Resource or Emerging Allergen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Sicily/Messina
      • Messina, Sicily/Messina, Italy, 98124
        • AOU Policlinico Universitario G. Martino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Allergic patients to fenugreek
Diagnostic test: Skin prick 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.
Non allergic patients to fenugreek
Diagnostic test: Skin prick 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous sensitization to fenugreek
Time Frame: 1 hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-reactivity between fenugreek and other legumes and other foods
Time Frame: 1 hour
Cutaneous sensitization to other legumes (lentil, bean, pea, soy, lupine and peanut) and other foods evaluated by the result of skin prick test in patients with suggestive history of allergic reactions to spices.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paola Miciullo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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