Fenugreek: an Emergent Allergen

Completed

• Conditions: Fenugreek Hypersensitivity - Cross-reactivity - Food Allergy
• Interventions: Diagnostic Test: Skin prick test

• Registration Number: NCT06257797
• Lead Sponsor: Paola Miciullo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allergic patients to fenugreek	Skin prick test	-
Non allergic patients to fenugreek	Skin prick test	-

Primary Outcome Measures

Name	Time	Method
Cutaneous sensitization to fenugreek	1 hour	Cutaneous sensitization to fenugreek evaluated by the result of skin prick test in patients with suggestive history of allergic reactions to spices.

Secondary Outcome Measures

Name	Time	Method
Cross-reactivity between fenugreek and other legumes and other foods	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.

Trial Locations

Locations (1)

AOU Policlinico Universitario G. Martino; 🇮🇹 Messina, Sicily/Messina, Italy