Polyphenol-rich Salicornia plus B vitamins to slow cognitive decline after lacunar stroke
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
Run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · NCT07353424 · Data updated 2026-11-12
This will test whether a Salicornia-derived polyphenol supplement combined with B vitamins can slow thinking and memory decline in people who had a lacunar stroke within the past year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 90 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other |
| Locations | 1 site (Seville) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT07353424 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 40–90 with an MRI-confirmed lacunar infarct within the past year, an mRS of 3 or less, able to swallow capsules, not currently taking vitamin or polyphenol supplements, and with expected life expectancy over 12 months.
✕Probably not a fit
Patients with severe disability (mRS >3), active cancer, dysphagia, allergies to halophytes, hyperthyroidism, current pregnancy or breastfeeding, recent use of vitamin/polyphenol supplements, or participation in another study are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SALACUNAR is a multicenter randomized controlled trial comparing a polyphenol-rich Salicornia extract plus B vitamins (B-salicornia) to standard clinical care in patients with lacunar infarcts. Three hundred patients aged 40–90 with MRI-confirmed lacunar stroke within the previous year and an mRS ≤3 will be randomized to receive the supplement or usual care. Primary outcomes include change in cognitive performance measured by the MOCA scale and biochemical markers such as homocysteine, with the sample size powered to detect a two-point MOCA difference. The supplement has shown prior safety and preliminary benefits on homocysteine and MOCA in smaller studies, and participants will attend site visits for follow-up.
Why it matters
Potential benefit: If effective, the supplement could slow cognitive decline after lacunar stroke and help preserve daily functioning.
How similar studies have gone: Small prior studies reported good safety and improvements in homocysteine levels and MOCA scores with similar Salicornia-based supplements, but large randomized trials are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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. Exclusion Criteria: * 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
Where it's running
-
Hospital Universitario Virgen Macarena
Seville, Spain Recruiting
Study contacts
- Study coordinator: Cristina López Azcárate
- Email: Salacunar@gmail.com
- Phone: +34608114878
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.