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)

NCT07353424 | Recruiting

• 1 other identifier: SALACUNAR (LACI-2-polyphenols)
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lacunar Stroke

Keywords

attack; food supplement; cognition

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  6 months

• Morisky-Green test count of returned treatment capsules.

  Confirm adequate adherence to dietary supplementation.

  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.

  6 months

Secondary Outcomes (2)

• Blood laboratory parameters (total cholesterol mg/dl).

  6 months

• Blood laboratory parameters (Low density lipoprotein cholesterol mg/dl).

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Food supplement to be taken once a day.

Dietary Supplement: B-salicornia

Clinical practice

NO INTERVENTION

Without intervention

Interventions

B-salicornia DIETARY_SUPPLEMENT

Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 6 months.

Treatment

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Joan Montaner Villalonga: collaborator

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Stroke, Lacunar

Condition Hierarchy (Ancestors)

Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thrombotic Stroke; Ischemic Stroke; Stroke; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

CRISTINA LÓPEZ AZCÁRATE

CONTACT

+34608114878; Salacunar@gmail.com

CARMEN DOMÍNGUEZ RUIZ

CONTACT

+34608114878; Salacunar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analysis of data
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mulcenter, randomized, parallel-group, pilot trial aimed at evaluating the effect of the administration of a food supplement based on of a dietary supplement based on salicornia extracts in patients with cerebral small vessel disease patients with cerebral small vessel disease recruited in 15 SNS hospitals compared to the usual clinical clinical practice (PROBE).

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 20, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

ES (1)