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)

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Six-minute walk test (6MWT) [Срок оценки: 6 months]
• Neuropsychological questionnaires: Montreal Cognitive Assessment (MOCA) [Срок оценки: 6 months]
• Blood laboratory parameters (homocysteine µmol/L). [Срок оценки: 6 months]
• Morisky-Green test count of returned treatment capsules. [Срок оценки: 6 months]
• Severity of the adverse event. [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Blood laboratory parameters (total cholesterol mg/dl). [Срок оценки: 6 months]
• Blood laboratory parameters (Low density lipoprotein cholesterol mg/dl). [Срок оценки: 6 months]

Критерии участия

Критерии включения

\- 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Hospital Universitario Virgen Macarena — Seville

Идентификаторы

NCT: NCT07353424 · SALACUNAR (LACI-2-polyphenols)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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