Lacunar StrokeSALACUNARNCT07353424
A Multicenter Randomized Clinical Trial Compared With Standard Clinical Practice to Evaluate the Efficacy of a Polyphenol-rich Salicornia Extract in the Progression of Cognitive Decline in a Cohort of Patients With Lacunar Infarcts (SALACUNAR)
A study testing B-salicornia in people with Lacunar Stroke, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
SALACUNAR (LACI-2-polyphenols) is a multi-center randomized controlled trial (RCT) to evaluate the effect of a polyphenol-rich supplement on small vessel neurovascular disease. Specifically, the compound to be tested is a dietary supplement based on Salicornia extract and B vitamins (B-salicornia), which in previous… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Lacunar Stroke
- What is being tested?
- B-salicornia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lacunar ischemic stroke, confirmed by cranial magnetic resonance imaging performed within the year prior to inclusion, who have an mRS of 3 or less at the time of inclusion will be included (independent patients or those who require assistance with walking). The inclusion age will be between 40 and 90 years.
Who cannot join
- Consumption of vitamin supplements or polyphenol supplements within 30 days prior to inclusion
- Hyperthyroidism
- mRS >3, serious illness, or expected life expectancy <12 months
- Dysphagia preventing intake of the study capsules
- Allergies or intolerance to halophytes
- Pregnant or breastfeeding
- Active neoplasia
- Participation in another study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
HOSPITAL UNIVERSITARIO VIRGEN MACARENA, +34608114878, Salacunar@gmail.com
About this study
Official title: A Multicenter Randomized Clinical Trial Compared With Standard Clinical Practice to Evaluate the Efficacy of a Polyphenol-rich Salicornia Extract in the Progression of Cognitive Decline in a Cohort of Patients With Lacunar Infarcts
SALACUNAR (LACI-2-polyphenols) is a multi-center randomized controlled trial (RCT) to evaluate the effect of a polyphenol-rich supplement on small vessel neurovascular disease. Specifically, the compound to be tested is a dietary supplement based on Salicornia extract and B vitamins (B-salicornia), which in previous studies has demonstrated a good safety profile and consistent effects in reducing homocysteine levels and improving cognitive outcomes (MOCA) in patients with lacunar infarcts. This has been used to calculate the sample size based on these endpoints. Considering an intragroup variability of the treatment groups (sigma) of 6.07, and accepting an alpha risk of 0.05, a sample of 150 patients per group would achieve a 1-beta statistical power greater than 0.8 in a two-tailed test for differences between means of at least two points on the MOCA scale.
Three hundred patients with lacunar infarcts diagnosed within the last year and confirmed by MRI performed as part of routine clinical practice will be included.
Read more
We will administer 500 mg/24 h of the dietary supplement B-Salicornia for six months (or the control group will be managed according to routine clinical practice) following a PROBE design.
Routine blood tests will be performed pre- and post-treatment, with routine vascular parameters such as lipids and homocysteine, as well as baseline and six-month assessments of neuropsychological and gait scales.
- Conditions
- Lacunar Stroke
- Being tested
- B-salicornia
- Keywords
- attack, food supplement, cognition
- Medical subject headings
- Stroke, Lacunar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-salicorniaDietary supplement
Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Food supplement to be taken once a day. Receives: Dietary Supplement: B-salicornia |
| Clinical practice | No intervention | Without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test (6MWT)
To evaluate changes in walking performance in patients who took the supplement compared to patients who followed standard clinical practice.
Measured: 6 months
Neuropsychological questionnaires: Montreal Cognitive Assessment (MOCA)
Assess possible improvements in cognitive function in patients taking the supplement versus patients following standard clinical practice.
Measured: 6 months
Blood laboratory parameters (homocysteine µmol/L).
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: 6 months
Morisky-Green test count of returned treatment capsules.
Confirm adequate adherence to dietary supplementation.
Measured: 6 months
Severity of the adverse event.
- Mild: No antidote or treatment required; brief hospitalisation. - MODERATE: Treatment modification required (e.g., dose change, addition of another drug), but discontinuation of the drug is not essential; prolonged administration of the drug is not essential; prolonged hospitalisation or treatment may be necessary, or specific hospitalisation or treatment may be necessary. - SEVERE: The adverse drug reaction is life-threatening and requires discontinuation of the drug. Drug administration should be discontinued and specific treatment instituted. - FATAL: An adverse drug reaction may directly or indirectly contribute to the death of the patient.
Measured: 6 months
Secondary outcomes (2)
Blood laboratory parameters (total cholesterol mg/dl).
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: 6 months
Blood laboratory parameters (Low density lipoprotein cholesterol mg/dl).
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacunar StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Mulcenter, randomized, parallel-group, pilot trial aimed at evaluating the effect of the administration of a food supplement based on of a dietary supplement based on salicornia extracts in patients with cerebral small vessel disease patients with cerebral small vessel disease recruited in 15 SNS hospitals compared to the usual clinical clinical practice (PROBE).
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Joan Montaner Villalonga
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353424
- Sponsor's protocol ID
- SALACUNAR (LACI-2-polyphenols)
- Acronym
- SALACUNAR
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Clinical Trial Compared With Standard Clinical Practice to Evaluate the Efficacy of a Polyphenol-rich Salicornia Extract in the Progression of Cognitive Decline in a Cohort of Patients With Lacunar Infarcts
- ClinicalTrials.gov ID
- NCT07353424
- Acronym / sponsor ID
- SALACUNAR / SALACUNAR (LACI-2-polyphenols)
- Conditions
- Lacunar Stroke
- Keywords
- attack, food supplement, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Joan Montaner Villalonga
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SALACUNAR (LACI-2-polyphenols) is a multi-center randomized controlled trial (RCT) to evaluate the effect of a polyphenol-rich supplement on small vessel neurovascular disease. Specifically, the compound to be tested is a dietary supplement based on Salicornia extract and B vitamins (B-salicornia), which in previous studies has demonstrated a good safety profile and consistent effects in reducing homocysteine levels and improving cognitive outcomes (MOCA) in patients with lacunar infarcts. This has been used to calculate the sample size based on these endpoints. Considering an intragroup variability of the treatment groups (sigma) of 6.07, and accepting an alpha risk of 0.05, a sample of 150 patients per group would achieve a 1-beta statistical power greater than 0.8 in a two-tailed test for differences between means of at least two points on the MOCA scale.
Three hundred patients with lacunar infarcts diagnosed within the last year and confirmed by MRI performed as part of routine clinical practice will be included.
We will administer 500 mg/24 h of the dietary supplement B-Salicornia for six months (or the control group will be managed according to routine clinical practice) following a PROBE design.
Routine blood tests will be performed pre- and post-treatment, with routine vascular parameters such as lipids and homocysteine, as well as baseline and six-month assessments of neuropsychological and gait scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mulcenter, randomized, parallel-group, pilot trial aimed at evaluating the effect of the administration of a food supplement based on of a dietary supplement based on salicornia extracts in patients with cerebral small vessel disease patients with cerebral small vessel disease recruited in 15 SNS hospitals compared to the usual clinical clinical practice (PROBE).
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: B-salicorniaFood supplement to be taken once a day. |
| Clinical practice | No intervention | –Without intervention |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with lacunar ischemic stroke, confirmed by cranial magnetic resonance imaging performed within the year prior to inclusion, who have an mRS of 3 or less at the time of inclusion will be included (independent patients or those who require assistance with walking). The inclusion age will be between 40 and 90 years.
Key exclusion criteria (8 listed)
- Consumption of vitamin supplements or polyphenol supplements within 30 days prior to inclusion
- Hyperthyroidism
- mRS >3, serious illness, or expected life expectancy <12 months
- Dysphagia preventing intake of the study capsules
- Allergies or intolerance to halophytes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-salicorniaDietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 6 months. | Dietary supplement | Treatment |
Primary outcome
Six-minute walk test (6MWT)
Time frame: 6 months
To evaluate changes in walking performance in patients who took the supplement compared to patients who followed standard clinical practice.
Neuropsychological questionnaires: Montreal Cognitive Assessment (MOCA)
Time frame: 6 months
Assess possible improvements in cognitive function in patients taking the supplement versus patients following standard clinical practice.
Blood laboratory parameters (homocysteine µmol/L).
Time frame: 6 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Morisky-Green test count of returned treatment capsules.
Time frame: 6 months
Confirm adequate adherence to dietary supplementation.
Severity of the adverse event.
Time frame: 6 months
- Mild: No antidote or treatment required; brief hospitalisation. - MODERATE: Treatment modification required (e.g., dose change, addition of another drug), but discontinuation of the drug is not essential; prolonged administration of the drug is not essential; prolonged hospitalisation or treatment may be necessary, or specific hospitalisation or treatment may be necessary. - SEVERE: The adverse drug reaction is life-threatening and requires discontinuation of the drug. Drug administration should be discontinued and specific treatment instituted. - FATAL: An adverse drug reaction may directly or indirectly contribute to the death of the patient.
2 secondary outcomes
Blood laboratory parameters (total cholesterol mg/dl).
Time frame: 6 months
Blood laboratory parameters (Low density lipoprotein cholesterol mg/dl).
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
Related trials for Lacunar Stroke
Active, not recruiting
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Neurologic Disorder, Paralysis
RecruitingPhase 4
Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
Lacunar Stroke, Stroke
RecruitingObservational study
Cerebral Small Vessel Disease Progression Dependent on Stroke Type
Cerebral Small Vessel Disease, Stroke
RecruitingObservational study
Retinal Vessel Leakage in Cerebral Small Vessel Disease
Cerebral Small Vessel Diseases, Lacunar Stroke
Recruiting
Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)
Lacunar Stroke, Small Vessel Cerebrovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-salicornia in people with Lacunar 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 1 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CRISTINA LÓPEZ AZCÁRATE (+34608114878, Salacunar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test (6MWT) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.