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) (SALACUNAR)

January 19, 2026 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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 (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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Food supplement to be taken once a day.
Dietary supplement: B-salicornia
Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 6 months.
No Intervention: Clinical practice
Without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-minute walk test (6MWT)
Time Frame: 6 months
To evaluate changes in walking performance in patients who took the supplement compared to patients who followed standard clinical practice.
6 months
Neuropsychological questionnaires: Montreal Cognitive Assessment (MOCA)
Time Frame: 6 months
Assess possible improvements in cognitive function in patients taking the supplement versus patients following standard clinical practice.
6 months
Blood laboratory parameters (homocysteine µmol/L).
Time Frame: 6 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
6 months
Morisky-Green test count of returned treatment capsules.
Time Frame: 6 months
Confirm adequate adherence to dietary supplementation.
6 months
Severity of the adverse event.
Time Frame: 6 months
- 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood laboratory parameters (total cholesterol mg/dl).
Time Frame: 6 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
6 months
Blood laboratory parameters (Low density lipoprotein cholesterol mg/dl).
Time Frame: 6 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Joan Montaner Villalonga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALACUNAR (LACI-2-polyphenols)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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