Using Salicornia extracts to improve neurovascular health

Halophyte Plants as a Dietary Supplement to Improve Neurovascular Health

This study is testing whether a food supplement made from the Salicornia plant can help improve brain and blood vessel health in healthy people and those with neurovascular conditions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Academic / other)
• Locations: 1 site (Sevilla)
• Trial ID: NCT06076122 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects and safety of a food supplement derived from halophyte plant extracts, specifically Salicornia, on neurovascular health. It involves healthy volunteers and patients with various neurovascular conditions, who will be randomized to receive either the supplement or a placebo for different treatment durations. The study aims to assess the neuroprotective properties of Salicornia extracts in a double-blind manner, ensuring unbiased results. Participants will undergo analytical controls at the beginning and end of the study to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates include healthy adults and patients with transient ischemic attack, minor stroke, or cerebral small vessel disease.

Not a fit: Patients with known neurovascular diseases or chronic illnesses requiring regular medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary intervention to enhance neurovascular health and potentially reduce the risk of stroke.

How similar studies have performed: While the use of halophyte extracts is relatively novel, similar studies exploring plant-based supplements for neuroprotection have shown promising results.

Eligibility criteria

Substudy A:

* Inclusion Criteria:

  1. Patients ≥18 years old
  2. Possibility of analytical controls at the beginning/end of the study.
  3. Willingness and ability to give informed consent.
* Exclusion Criteria:

  1. Known neurovascular disease.
  2. Other chronic diseases for which the subject is taking medication on a regular basis.
  3. Hyperthyroidism according to the investigator's criteria.
  4. Volunteers taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
  5. Severe illness with life expectancy of less than three months.
  6. Known allergies or intolerance to halophyte plants.
  7. Pregnant or lactating women.
  8. Presence of active neoplastic disease.
  9. Having participated in another clinical trial with medicinal products in the 30 days prior to the screening visit, or intending to do so during their participation in this study.
  10. Habitual consumption of halophyte plants.
  11. Patients who, at the investigator's discretion, are not able to comply with the study protocol.

Substudy B:

* Inclusion criteria:

  1. Patients ≥18 years old.
  2. Patients with typical symptoms lasting less than 24 hours seen at the HUVM classified as TIA or minor stroke (if Diffusion weighted imaging (DWI) positive on magnetic resonance imaging (MRI)) during the last year.
  3. Have a neuroimaging performed at the time of the acute episode that rules out other non-vascular lesions.
  4. Willingness and ability to give informed consent.
* Exclusion criteria:

  1. Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
  2. Having participated in another clinical trial with medicinal products in the 30 days prior to the screening visit, or intending to do so during their participation in this study.
  3. Hyperthyroidism at the investigator's discretion.
  4. Dysphagia that prevents the intake of the study treatment.
  5. Patients dependent for basic activities of daily living (mRS \>3) or with severe disease with life expectancy of less than 12 months.
  6. Known allergies or intolerance to halophyte plants.
  7. Habitual consumption of halophyte plants.
  8. Pregnant or lactating women.
  9. Presence of active neoplastic disease.
  10. Patients who, at the investigator's discretion, are unable to comply with the study protocol.

Substudy C:

* Inclusion criteria:

  1. Patients ≥18 years of age.
  2. Lacunar syndrome with acute ischaemic lesion on neuroimaging of less than 1.5 cm maximum diameter.
  3. Willingness and ability to give informed consent.
* Exclusion criteria:

  1. Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
  2. Hyperthyroidism at the investigator's discretion.
  3. Claustrophobia or morbid obesity (IMT \>40) precluding performance of MRI 3 Tesla.
  4. Patients dependent for basic activities of daily living (mRS \>3) or with severe disease with an expected life expectancy of less than 12 months.
  5. Dysphagia that prevents the intake of the study treatment.
  6. Known allergies or intolerances to halophyte plants.
  7. Pregnant or breastfeeding women.
  8. Presence of active neoplastic disease.
  9. Having participated in another clinical trial with medicinal products in the 30 days prior to the screening visit, or intending to do so during their participation in this study.
  10. Habitual consumption of halophyte plants.
  11. Patients who, at the investigator's discretion, are not able to comply with the study protocol.

Substudy D:

* Inclusion criteria:

  1. Patient with carotid stenosis that warrants treatment in one of the following cases:

     * Symptomatic carotid stenosis \>50% with stroke within 6 months prior to inclusion and not disabling at the time of inclusion.
     * Asymptomatic carotid stenosis \>70% provided some of the following criteria are met:

     I. Presence of silent stroke on neuroimaging.

     II. Stenosis with progression (\>20%).

     III. Soft or ulcerated (unstable) plaque.

     IV. Occlusion of contralateral internal carotid artery (ICA).

     V. Impaired haemodynamic reserve.
  2. Receive carotid angioplasty and stenting (CAS) of said artery within a maximum of one month after inclusion and with a minimum of one week of taking the treatment from inclusion to intervention.
  3. Be able to orally take the dietary supplement/placebo from the event until just prior to the intervention.
  4. Patients ≥18 years.
  5. Willingness and ability to give informed consent.
* Exclusion criteria:

  1. Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
  2. Hyperthyroidism at the investigator's discretion.
  3. Claustrophobia or morbid obesity preventing the performance of MRI 1.5 Tesla.
  4. Severe disease with expected life expectancy of less than one month.
  5. Dysphagia preventing the intake of the study treatment.
  6. Known allergies or intolerance to halophyte plants.
  7. Pregnant or lactating women.
  8. Presence of active neoplastic disease.
  9. Having participated in another clinical trial with medicinal products in the 30 days prior to the screening visit, or intending to do so during their participation in this study.
  10. Habitual consumption of halophyte plants.
  11. Patients who, at the investigator's discretion, are not able to comply with the study protocol.

Where this trial is running

Sevilla

• Hospital Universitario Virgen Macarena — Sevilla, Spain (Recruiting)

Study contacts

• Principal investigator: Joan Montaner Villalonga — Virgen Macarena (HUVM) and Virgen del Rocío University Hospitals (HUVR) and Institute of Biomedicine of Seville (iBIs)

Conditions Stroke; Ischemic Stroke; Neurovascular Injury; Brain Ischemia; Polyphenol; Salicornia; Brain ischemia; Neuroprotection