NCT07353424 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)
| NCT ID | NCT07353424 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| Condition | Lacunar Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07353424 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Lacunar Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07353424 currently recruiting?
Yes, NCT07353424 is actively recruiting participants. Contact the research team at Salacunar@gmail.com for enrollment information.
Where is the NCT07353424 trial being conducted?
This trial is being conducted at Seville, Spain.
Who is sponsoring the NCT07353424 clinical trial?
NCT07353424 is sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. The trial plans to enroll 300 participants.
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