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NCT Number: NCT07353424

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 (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.

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Key information

Conditions

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

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location status: Recruiting

Location contact

HOSPITAL UNIVERSITARIO VIRGEN MACARENA

CONTACT

[email protected]

+34608114878

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-salicornia

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Morisky-Green test count of returned treatment capsules.

    Time frame: 6 months

    Confirm adequate adherence to dietary supplementation.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

CARMEN DOMÍNGUEZ RUIZ

CONTACT

[email protected]

+34608114878

CRISTINA LÓPEZ AZCÁRATE

CONTACT

[email protected]

+34608114878

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Joan Montaner Villalonga

Registry information

Official study 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

Acronym: SALACUNAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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