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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)

RecruitingNAAges 40 Years - 90 YearsAllFundación Pública Andaluza para la gestión de la …
NCT07353424 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • B-salicornia
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Where

1 site
Hospital Universitario Virgen Macarena
Seville, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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