Fenugreek: an Emergent Allergen

NCT ID: NCT06257797

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fenugreek Hypersensitivity - Cross-reactivity - Food Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Allergic patients to fenugreek

Skin prick test

Intervention Type 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.

Non allergic patients to fenugreek

Skin prick test

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Paola Miciullo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paola Miciullo

Associated Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOU Policlinico Universitario G. Martino

Messina, Sicily/Messina, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3/24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.