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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B-salicornia.
- Who it may be relevant to
- Registry conditions: Lacunar Stroke. Basic parameters: 40 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Dietary supplement B-salicornia
Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 6 months.
Primary outcome measures
- Six-minute walk test (6MWT) [Time frame: 6 months]
- Neuropsychological questionnaires: Montreal Cognitive Assessment (MOCA) [Time frame: 6 months]
- Blood laboratory parameters (homocysteine µmol/L). [Time frame: 6 months]
- Morisky-Green test count of returned treatment capsules. [Time frame: 6 months]
- Severity of the adverse event. [Time frame: 6 months]
Secondary outcome measures (2)
- Blood laboratory parameters (total cholesterol mg/dl). [Time frame: 6 months]
- Blood laboratory parameters (Low density lipoprotein cholesterol mg/dl). [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Hospital Universitario Virgen Macarena — Seville
Identifiers
NCT: NCT07353424 · SALACUNAR (LACI-2-polyphenols)