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NCT Number: NCT07652853

Allergenic Risk Assessment of Hemp Seed

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.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

All study-specific examinations are performed during the enrollment visit, which takes place during a routine medical visit

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

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

    Time frame: enrollment visit

    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.

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

    Time frame: enrollment visit

    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.

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

    Time frame: enrollment visit

    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.

Secondary outcomes

  1. Proportion of patients sensitized to hemp leaves

    Time frame: enrollment visit

    To estimate the proportion of patients sensitized to hemp leaves among:

    subjects allergic or suspected of being allergic to cannabis (including hemp), subjects allergic to tree nuts (e.g., hazelnuts or walnuts), subjects allergic to seeds (e.g., sunflower, sesame, etc.)

  2. Describe the IgE reactivity profiles to hemp leaves

    Time frame: enrollment visit

    IgE reactivity profiles based on four tests :

    • total protein extract of male hemp flowers (≥ 10 ng/mL);
    • total protein extract of female hemp flowers (≥ 10 ng/mL);

    Commercial extracts used in routine clinical practice:

    • Hemp extract (ImmunoCAP) (> 0.35 kUA/L);
    • Can s 3 (ImmunoCAP) (> 0.35 kUA/L).
  3. Identify the allergenic protein components mediating IgE reactivity to hemp seeds and hemp flowers

    Time frame: enrollment visit

    • Indirect fluorometric ELISA
    • Western Blot
    • Human mast cell or humanized rat basophil assays

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie Hautefort

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Louise GUYOT, Dr

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: ARCANA-Clinic

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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