Allergenic Risk Assessment of Hemp Seed

NCT07652853 | Not Yet Recruiting

• 2 other identifiers: 49RC26_0172ANSM
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cannabis sativa is an annual herbaceous plant from the Cannabaceae family that has been cultivated and consumed by humans for thousands of years. Its main uses include fiber production, seeds for human and animal food, and psychoactive medications. Indeed, cannabis is the most commonly consumed illicit substance among adolescents and poses a major public health issue. Allergic risks associated with cannabis have already been documented. At the same time, the consumption of hemp seeds is increasing due to the current agro-food context and the rise of vegan and vegetarian diets. This new food raises questions about its potential allergic risks, especially since the prevalence and severity of food allergies have been steadily increasing over the years. In this context, cases of anaphylaxis related to hemp seeds have already been reported. However, the potential allergic risk associated with hemp seeds remains largely unstudied to date. Several reasons make research into hemp seed allergies relevant: i) increased exposure to Cannabis sativa in its various forms, with the possibility of finding identical or similar proteins in the seeds; ii) changes in dietary habits, with the vegan trend encouraging the consumption of many seeds, including hemp seeds.

Conditions

Cannabis; Allergens

Keywords

Hemp seed

Outcome Measures

Primary Outcomes (3)

• Proportion of patients sensitized to hemp seeds in 3 differents population of patients (cannabis , tree nuts and seeds allergy)

  This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which i) Skin prick tests using native hemp seeds with positive results defined as: Wheal diameter ≥ 6 mm and Erythema larger than the wheal A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is \< 6 mm.

  enrollment visit

• Proportion of patients sensitized to hemp seeds in 3 differents population of patients (cannabis , tree nuts and seeds allergy)

  This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which ii) IgE reactivity to a total protein extract of hemp seed (≥ 10 ng/mL) A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is \< 6 mm.

  enrollment visit

• Proportion of patients sensitized to hemp seeds in 3 differents population of patients (cannabis , tree nuts and seeds allergy)

  This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which iii) Basophil activation test (BAT) with a positivity threshold set at \> 10% degranulation. A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is \< 6 mm.

  enrollment visit

Secondary Outcomes (3)

• Proportion of patients sensitized to hemp leaves

  enrollment visit

• Describe the IgE reactivity profiles to hemp leaves

  enrollment visit

• Identify the allergenic protein components mediating IgE reactivity to hemp seeds and hemp flowers

  enrollment visit

Study Arms (3)

Cannabis allergy

EXPERIMENTAL

Diagnostic Test: blood sample and skin prick tests

Tree nuts allergy

EXPERIMENTAL

Diagnostic Test: blood sample and skin prick tests

Seeds allergy

EXPERIMENTAL

Diagnostic Test: blood sample and skin prick tests

Interventions

blood sample and skin prick tests DIAGNOSTIC_TEST

Blood sample and skin prick tests in addition to the blood tests and skin prick tests originally scheduled for the patient's care

Cannabis allergy; Seeds allergy; Tree nuts allergy

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 2 years or older
• Belonging to one or more of the target populations:
• i) Individuals with known or suspected cannabis allergy: Allergy or suspected allergy to hemp seed (HS) defined by A suggestive clinical history of HS allergy and Positive skin prick test (SPT) to HS (≥ 6 mm with erythema exceeding the control papule) and/or Basophil activation test (BAT) confirming HS allergy diagnosis OR Allergy or suspected allergy to hemp flower (female or male) defined by a suggestive clinical history of hemp allergy and positive SPT to hemp flower (≥ 6 mm with erythema) and/or ImmunoCAP IgE to hemp \> 0.35 KU/L ii) Individuals allergic to tree nuts (hazelnut or walnut): Allergy to walnut defined by a suggestive clinical history of IgE-mediated walnut allergy and positive SPT to walnut (≥ 8 mm) and IgE to Jug r 1, Jug r 2, or Jug r 3 \> 1 KU/L and/or BAT confirming walnut allergy diagnosis OR Allergy to hazelnut defined by a suggestive clinical history of IgE-mediated hazelnut allergy and positive SPT to hazelnut (≥ 8 mm) and IgE to Cor a 9, Cor a 11, Cor a 14, or Cor a 8 \> 1 KU/L and/or BAT confirming hazelnut allergy diagnosis iii) Individuals allergic to seeds (sesame, flax, pumpkin, sunflower): Allergy to sesame defined by a suggestive clinical history of IgE-mediated sesame allergy and positive SPT to sesame (≥ 6 mm) and/or IgE to sesame and/or molecular components (Ses i 1 to Ses i 7) \> 0.35 KU/L and/or BAT confirming sesame allergy diagnosis OR Allergy to flaxseed defined by a suggestive clinical history of IgE-mediated flaxseed allergy and positive SPT to flaxseed (≥ 6 mm) and/or IgE to flaxseed \> 0.35 KU/L and/or BAT confirming flaxseed allergy diagnosis OR Allergy to pumpkin seed defined by a suggestive clinical history of IgE-mediated pumpkin seed allergy and positive SPT to pumpkin seed (≥ 6 mm) and/or IgE to pumpkin seed \> 0.35 KU/L and/or BAT confirming pumpkin seed allergy diagnosis OR Allergy to sunflower seed defined by a suggestive clinical history of IgE-mediated sunflower seed allergy and positive SPT to sunflower seed (≥ 6 mm) and/or IgE to sunflower seed \> 0.35 KU/L and/or BAT confirming sunflower seed allergy diagnosis
• Patients referred to the Allergy Unit at Angers University Hospital (CHU d'Angers) for skin prick testing, either in outpatient consultation or during hospitalization
• Patients affiliated with or beneficiaries of a social security system
• Patient or legal representative having signed an informed consent form

You may not qualify if:

• Pregnant women or women in labor
• Individuals deprived of liberty by an administrative or judicial decision
• Individuals undergoing involuntary psychiatric care
• Adults under a legal protection measure
• Individuals unable to express their consent
• Poor understanding of the French language
• Patients whose skin reactivity prevents the interpretation of the tests

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Louise GUYOT, Dr

CONTACT

02 41 35 36 37; Louise_Guyot@chu-angers.fr

Aurélie Hautefort

CONTACT

02 41 35 36 37; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share