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.
None
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
Parallel
B-salicornia
Dietary supplementDietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 6 months.
Six-minute walk test (6MWT)
To evaluate changes in walking performance in patients who took the supplement compared to patients who followed standard clinical practice.
Neuropsychological questionnaires: Montreal Cognitive Assessment (MOCA)
Assess possible improvements in cognitive function in patients taking the supplement versus patients following standard clinical practice.
Blood laboratory parameters (homocysteine µmol/L).
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Morisky-Green test count of returned treatment capsules.
Confirm adequate adherence to dietary supplementation.
Blood laboratory parameters (total cholesterol mg/dl).
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Blood laboratory parameters (Low density lipoprotein cholesterol mg/dl).
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead sponsor
Joan Montaner Villalonga
Collaborator
