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StrokeNCT06076122

Salicornia for Neurovascular Health Improve

A study testing Food supplement based on Salicornia extracts in people with Stroke and Ischemic Stroke, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is evaluate the effect and safety of the administration of a food supplement based on halophyte plant extracts versus placebo in the neurovascular healthy. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Ischemic Stroke, Neurovascular Injury
What is being tested?
Food supplement based on Salicornia extracts
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
1 siteSpain
Study dates
15 Sep 2022to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients ≥18 years old
  • Possibility of analytical controls at the beginning/end of the study.
  • Willingness and ability to give informed consent.
  • Patients ≥18 years old.
  • 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.
  • Have a neuroimaging performed at the time of the acute episode that rules out other non-vascular lesions.
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  • Willingness and ability to give informed consent.
  • Patients ≥18 years of age.
  • Lacunar syndrome with acute ischaemic lesion on neuroimaging of less than 1.5 cm maximum diameter.
  • Willingness and ability to give informed consent.
  • 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:
  • Presence of silent stroke on neuroimaging.
  • Stenosis with progression (>20%).
  • Soft or ulcerated (unstable) plaque.
  • Occlusion of contralateral internal carotid artery (ICA).
  • Impaired haemodynamic reserve.
  • 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.
  • Be able to orally take the dietary supplement/placebo from the event until just prior to the intervention.
  • Patients ≥18 years.
  • Willingness and ability to give informed consent.

Who cannot join

  • Known neurovascular disease.
  • Other chronic diseases for which the subject is taking medication on a regular basis.
  • Hyperthyroidism according to the investigator's criteria.
  • Volunteers taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
  • Severe illness with life expectancy of less than three months.
  • Known allergies or intolerance to halophyte plants.
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  • Pregnant or lactating women.
  • Presence of active neoplastic disease.
  • 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.
  • Habitual consumption of halophyte plants.
  • Patients who, at the investigator's discretion, are not able to comply with the study protocol.
  • Substudy B:
  • Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
  • 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.
  • Hyperthyroidism at the investigator's discretion.
  • Dysphagia that prevents the intake of the study treatment.
  • Patients dependent for basic activities of daily living (mRS >3) or with severe disease with life expectancy of less than 12 months.
  • Known allergies or intolerance to halophyte plants.
  • Habitual consumption of halophyte plants.
  • Pregnant or lactating women.
  • Presence of active neoplastic disease.
  • Patients who, at the investigator's discretion, are unable to comply with the study protocol.
  • Substudy C:
  • Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
  • Hyperthyroidism at the investigator's discretion.
  • Claustrophobia or morbid obesity (IMT >40) precluding performance of MRI 3 Tesla.
  • Patients dependent for basic activities of daily living (mRS >3) or with severe disease with an expected life expectancy of less than 12 months.
  • Dysphagia that prevents the intake of the study treatment.
  • Known allergies or intolerances to halophyte plants.
  • Pregnant or breastfeeding women.
  • Presence of active neoplastic disease.
  • 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.
  • Habitual consumption of halophyte plants.
  • Patients who, at the investigator's discretion, are not able to comply with the study protocol.
  • Substudy D:
  • Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
  • Hyperthyroidism at the investigator's discretion.
  • Claustrophobia or morbid obesity preventing the performance of MRI 1.5 Tesla.
  • Severe disease with expected life expectancy of less than one month.
  • Dysphagia preventing the intake of the study treatment.
  • Known allergies or intolerance to halophyte plants.
  • Pregnant or lactating women.
  • Presence of active neoplastic disease.
  • 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.
  • Habitual consumption of halophyte plants.
  • Patients who, at the investigator's discretion, are not able to comply with the study protocol.

Trial locations and contacts

1 site in 1 country.

Spain1 site, 1 recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Ana María Najar, +34 954787742, anmoyano@us.es

    Recruiting

Other trials in Spain

About this study

Official title: Halophyte Plants as a Dietary Supplement to Improve Neurovascular Health

The purpose of this study is evaluate the effect and safety of the administration of a food supplement based on halophyte plant extracts versus placebo in the neurovascular healthy.

Read the detailed description

After being informed about the study and giving written informed consent, healthy volunteers (substudy A), patients with transient ischemic attack (TIA) or MINOR stroke (substudy B), patients with cerebral small vessel disease (substudy C) and patients who have suffered a non-disabling stroke and are going to receive carotid angioplasty and stenting (CAS) (substudy D) will be randomized in double-blind manner (participant and investigator) to take a food supplement based on halophyte plant extracts (1 g once a day) or placebo (once a day) for a treatment period of 3 months (substudy A), 11 months (substudy B), 1 year (substudy C) or 7-30 days (substudy D). Participants in substudy A will be twice as likely to be assigned to the experimental treatment as to placebo (2:1 ratio), while those in substudies B, C and D will be equally likely (1:1 ratio).

Being tested
Food supplement based on Salicornia extracts, Placebo
Keywords
Polyphenol, Salicornia, Brain ischemia, Neuroprotection, Halophytes
Medical subject headings
Stroke, Ischemic Stroke, Brain Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food supplement based on Salicornia extractsDietary supplement

    Also called Salicornia extracts

    Freshly Salicornia ramosissima plants were recollected. Its aerial part were left to dry and hydroalcoholic extracts were produced by the company Extractos Vegetales S.A. (EVESA) (Cadiz, Spain [https://evesa.com/]). The Salicornia extracts were encapsulated by BIO-DIS laboratories (Seville, Spain [https://www.bio-dis.com/]), experts in food supplements and certified for such procedures.

  • PlaceboDietary supplement

    Placebo capsules physically equal to the Salicornia extracts capsules

Study groups in NCT06076122
Study groupRoleWhat they receive
Food supplement based on Salicornia extractsExperimentalParticipants will receive food supplement based on halophyte plant (Salicornia) extracts, 1 g (two 0.5 gram capsules) orally once a day for a treatment period of 3 months (substudy A), 11 months (substudy B), 1 year (substudy C) or 7-30 days (substudy D).
Receives: Dietary Supplement: Food supplement based on Salicornia extracts
PlaceboPlacebo comparatorParticipants will receive two capsules once a day of placebo physically equal to the nutritional supplement for a treatment period of 3 months (substudy A), 11 months (substudy B), 1 year (substudy C) or 7-30 days (substudy D).
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    The safety and tolerability of the supplement shall be quantified in terms of the incidence of adverse events. The frequency of adverse events and the percentage of adverse events causing subject withdrawal from the study shall be determined.

    Measured: Through study completion, up to 1 year.

Secondary outcomes (12)

  1. Participants with change from baseline in blood cholesterol

    Significant changes in blood cholesterol will be calculated after taking each of the treatments compared to the baseline value.

    Measured: Baseline and up to 1 year.

  2. Participants with change from baseline in blood homocysteine

    Significant changes in blood homocysteine will be calculated after taking each of the treatments compared to the baseline value.

    Measured: Baseline and up to 1 year.

  3. Participants with change from baseline in blood glycosylated haemoglobin

    Significant changes in glycosylated haemoglobin will be calculated after taking each of the treatments compared to the baseline value.

    Measured: Baseline and up to 1 year.

  4. Participants with change from baseline in blood Fatty acid-binding protein 2 (FABP2)

    Significant changes in FABP2 will be calculated after taking each of the treatments compared to the baseline value. FABP2 will be measure using Proximity extension assay (PEA).

    Measured: Baseline and up to 1 year.

  5. Change from baseline in the degree of cognitive impairment (in substudies B and C)

    It will be checked whether there are significant changes in the degree of cognitive impairment after taking the treatment compared to its baseline assessment between the two treatment groups by applying The Montreal Cognitive Assessment (MOCA) test. The scores range from 0 to 30, with 26 being considered normal or greater.

    Measured: Baseline, 6 months and 1 year.

  6. Changes in Functional Ambulatory Profile (FAP) (in substudies B and C)

    It will be checked whether there are significant changes in the FAP after taking the treatment compared to its baseline assessment between the two treatment groups which will be automatically measured by GAITRite® equipment before and after the Six minutes Walking Test (6MWT). FAP score is calculated by subtracting points from a maximum score of 100, being 30 the lowest possible score. In the nondisabled adult population, FAP score ranges from 95 to 100 points.

    Measured: Baseline, 6 months and 1 year.

  7. Efficacy in preventing new major cardiovascular events (in substudies B and C).

    Incidence of major cardiovascular events (acute myocardial infarction, ischaemic stroke, systemic embolism or death of cardiovascular origin).

    Measured: Baseline, 6 months and 1 year.

  8. Changes in average systolic blood pressure (in substudy C)

    Spacelabs' OnTrak ambulatory blood pressure monitor (ABPM) (extensively tested and validated) will measure the patient's ambulatory systolic blood pressure outside the hospital-medical setting for 24 hours after the visit and the average will be calculated.

    Measured: Baseline, 6 months and 1 year.

  9. Changes in average diastolic blood pressure (in substudy C)

    Spacelabs' OnTrak ambulatory blood pressure monitor (ABPM) (extensively tested and validated) will measure the patient's ambulatory diastolic blood pressure outside the hospital-medical setting for 24 hours after the visit.

    Measured: Baseline, 6 months and 1 year.

  10. Changes in pulsatility index in middle cerebral artery (MCA) (in substudy C)

    It will be checked whether there are significant changes in the pulsatility index in after taking the treatment compared to its baseline assessment between the two treatment groups. The pulsatility index (PI) is a calculated flow parameter in ultrasound, derived from the maximum, minimum, and mean transcranial Doppler frequency shifts during a defined cardiac cycle.

    PI = (peak systolic velocity - minimal diastolic velocity) / (mean velocity)

    Measured: Baseline, 6 months and 1 year.

  11. Efficacy in preventing new lesions related to small vessel disease from baseline (in substudy C).

    Number of new lesions related to small vessel disease (white matter hyperintensities, lacunes, cerebral microbleeds or atrophy) from baseline, assessed by 3 Teslas cranial magnetic resonance imaging (MRI).

    Measured: Baseline and 1 year.

  12. Efficacy in preventing new diffusion-weighted imaging (DWI) cerebral lesions from baseline (in substudy D)

    Number of new diffusion-weighted imaging (DWI) cerebral lesions from baseline, assessed by 1.5 Teslas cranial MRI.

    Measured: Final visit (from day 7 to day 30)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start15 Sep 2022
  3. Primary completion9 Feb 2023
  4. Study completion31 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentre, randomised, triple-blind, parallel-group, placebo-controlled pilot trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06076122
Sponsor's protocol ID
HALOPHYTES
Status last verified
Jul 2023
First submitted
4 Sep 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Analyzed data will be published as a whole

Publications

  • Perez-Sanchez S, Del Rio C, Nunez-Jurado D, Najar AM, Ocete RF, Azcarate CL, Dominguez-Ruiz C, de Torres Chacon R, Barragan-Prieto A, Dominguez-Mayoral A, Sevilla-Bravo A, Fernandez-Garcia JL, Magni E, Busquier T, Leon-Justel A, Montaner J. Polyphenol-rich Salicornia extract in lacunar stroke: a pilot randomised trial of safety and exploratory clinical outcomes. Eur Stroke J. 2026 May 6;11(5):aakag049. doi: 10.1093/esj/aakag049.

    PubMed 42160741

Questions about this trial

What is this clinical trial studying?

A study testing Food supplement based on Salicornia extracts in people with Stroke and Ischemic Stroke, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Through study completion, up to 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06076122, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

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