The purpose of this study is evaluate the effect and safety of the administration of a food supplement based on halophyte plant extracts versus placebo in the neurovascular healthy.
After being informed about the study and giving written informed consent, healthy volunteers (substudy A), patients with transient ischemic attack (TIA) or MINOR stroke (substudy B), patients with cerebral small vessel disease (substudy C) and patients who have suffered a non-disabling stroke and are going to receive carotid angioplasty and stenting (CAS) (substudy D) will be randomized in double-blind manner (participant and investigator) to take a food supplement based on halophyte plant extracts (1 g once a day) or placebo (once a day) for a treatment period of 3 months (substudy A), 11 months (substudy B), 1 year (substudy C) or 7-30 days (substudy D). Participants in substudy A will be twice as likely to be assigned to the experimental treatment as to placebo (2:1 ratio), while those in substudies B, C and D will be equally likely (1:1 ratio).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
350
Freshly Salicornia ramosissima plants were recollected. Its aerial part were left to dry and hydroalcoholic extracts were produced by the company Extractos Vegetales S.A. (EVESA) (Cadiz, Spain \[https://evesa.com/\]). The Salicornia extracts were encapsulated by BIO-DIS laboratories (Seville, Spain \[https://www.bio-dis.com/\]), experts in food supplements and certified for such procedures.
Placebo capsules physically equal to the Salicornia extracts capsules
Hospital Universitario Virgen Macarena
Seville, Spain
RECRUITINGIncidence of adverse events
The safety and tolerability of the supplement shall be quantified in terms of the incidence of adverse events. The frequency of adverse events and the percentage of adverse events causing subject withdrawal from the study shall be determined.
Time frame: Through study completion, up to 1 year.
Participants with change from baseline in blood cholesterol
Significant changes in blood cholesterol will be calculated after taking each of the treatments compared to the baseline value.
Time frame: Baseline and up to 1 year.
Participants with change from baseline in blood homocysteine
Significant changes in blood homocysteine will be calculated after taking each of the treatments compared to the baseline value.
Time frame: Baseline and up to 1 year.
Participants with change from baseline in blood glycosylated haemoglobin
Significant changes in glycosylated haemoglobin will be calculated after taking each of the treatments compared to the baseline value.
Time frame: Baseline and up to 1 year.
Participants with change from baseline in blood Fatty acid-binding protein 2 (FABP2)
Significant changes in FABP2 will be calculated after taking each of the treatments compared to the baseline value. FABP2 will be measure using Proximity extension assay (PEA).
Time frame: Baseline and up to 1 year.
Change from baseline in the degree of cognitive impairment (in substudies B and C)
It will be checked whether there are significant changes in the degree of cognitive impairment after taking the treatment compared to its baseline assessment between the two treatment groups by applying The Montreal Cognitive Assessment (MOCA) test. The scores range from 0 to 30, with 26 being considered normal or greater.
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Time frame: Baseline, 6 months and 1 year.
Changes in Functional Ambulatory Profile (FAP) (in substudies B and C)
It will be checked whether there are significant changes in the FAP after taking the treatment compared to its baseline assessment between the two treatment groups which will be automatically measured by GAITRite® equipment before and after the Six minutes Walking Test (6MWT). FAP score is calculated by subtracting points from a maximum score of 100, being 30 the lowest possible score. In the nondisabled adult population, FAP score ranges from 95 to 100 points.
Time frame: Baseline, 6 months and 1 year.
Efficacy in preventing new major cardiovascular events (in substudies B and C).
Incidence of major cardiovascular events (acute myocardial infarction, ischaemic stroke, systemic embolism or death of cardiovascular origin).
Time frame: Baseline, 6 months and 1 year.
Changes in average systolic blood pressure (in substudy C)
Spacelabs' OnTrak ambulatory blood pressure monitor (ABPM) (extensively tested and validated) will measure the patient's ambulatory systolic blood pressure outside the hospital-medical setting for 24 hours after the visit and the average will be calculated.
Time frame: Baseline, 6 months and 1 year.
Changes in average diastolic blood pressure (in substudy C)
Spacelabs' OnTrak ambulatory blood pressure monitor (ABPM) (extensively tested and validated) will measure the patient's ambulatory diastolic blood pressure outside the hospital-medical setting for 24 hours after the visit.
Time frame: Baseline, 6 months and 1 year.
Changes in pulsatility index in middle cerebral artery (MCA) (in substudy C)
It will be checked whether there are significant changes in the pulsatility index in after taking the treatment compared to its baseline assessment between the two treatment groups. The pulsatility index (PI) is a calculated flow parameter in ultrasound, derived from the maximum, minimum, and mean transcranial Doppler frequency shifts during a defined cardiac cycle. PI = (peak systolic velocity - minimal diastolic velocity) / (mean velocity)
Time frame: Baseline, 6 months and 1 year.
Efficacy in preventing new lesions related to small vessel disease from baseline (in substudy C).
Number of new lesions related to small vessel disease (white matter hyperintensities, lacunes, cerebral microbleeds or atrophy) from baseline, assessed by 3 Teslas cranial magnetic resonance imaging (MRI).
Time frame: Baseline and 1 year.
Efficacy in preventing new diffusion-weighted imaging (DWI) cerebral lesions from baseline (in substudy D)
Number of new diffusion-weighted imaging (DWI) cerebral lesions from baseline, assessed by 1.5 Teslas cranial MRI.
Time frame: Final visit (from day 7 to day 30)