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)

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.

NCT Number	NCT07353424
Lead Sponsor	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Collaborators: Joan Montaner Villalonga
Conditions	Lacunar Stroke
Enrollment	300 participants
Start Date	2025-06-01
Primary Completion	2026-06-01 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-20