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| Name | Class |
|---|---|
| Joan Montaner Villalonga | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Food supplement to be taken once a day. |
|
| Clinical practice | No Intervention | Without intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-salicornia | Dietary Supplement | Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Blood laboratory parameters (Low density lipoprotein cholesterol mg/dl). |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CRISTINA LÓPEZ AZCÁRATE | Contact | +34608114878 | Salacunar@gmail.com | |
| CARMEN DOMÍNGUEZ RUIZ | Contact | +34608114878 | Salacunar@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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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).
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Statistical analysis of data
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. |
| 6 months |
| ID | Term |
|---|---|
| D059409 | Stroke, Lacunar |
| ID | Term |
|---|---|
| D059345 | Cerebral Small Vessel Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000083244 | Thrombotic Stroke |
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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