NCT07353424Recruiting
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 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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Diseases
- Stroke
- NCT number
- NCT07353424
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Jun 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Consumption of vitamin supplements or polyphenol supplements within 30 days prior to inclusion
Other illness
- mRS \>3, serious illness, or expected life expectancy \<12 months
- Allergies or intolerance to halophytes
Other
- Hyperthyroidism
- Dysphagia preventing intake of the study capsules
- Pregnant or breastfeeding
- Active neoplasia
- Participation in another study
Who the study is looking for
- \- 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.
Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.