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)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla300 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Lacunar Stroke

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Neuropsychological questionnaires: Montreal Cognitive Assessment (MOCA)

Assess possible improvements in cognitive function in patients taking the supplement versus patients following standard clinical practice.

Time frame: 6 months

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.

Time frame: 6 months

Morisky-Green test count of returned treatment capsules.

Confirm adequate adherence to dietary supplementation.

Time frame: 6 months

Severity of the adverse event.

\- Mild: No antidote or treatment required; brief hospitalisation. - MODERATE: Treatment modification required (e.g., dose change, addition of another drug), but discontinuation of the drug is not essential; prolonged administration of the drug is not essential; prolonged hospitalisation or treatment may be necessary, or specific hospitalisation or treatment may be necessary. - SEVERE: The adverse drug reaction is life-threatening and requires discontinuation of the drug. Drug administration should be discontinued and specific treatment instituted. - FATAL: An adverse drug reaction may directly or indirectly contribute to the death of the patient.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

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.

Time frame: 6 months

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)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts