The study is divided into two phases: Phase 1 (observational) and Phase 2 (dietary intervention). The goal of Phase 1 is to assess the nutritional status and dietary habits of two cohorts of patients with CADASIL and CAA. A specific aim is to evaluate adherence to the Mediterranean Diet. The objectives include analyzing patients' nutritional status, lean and fat mass, basal metabolism, and total energy expenditure. It also aims to assess the relationship between adherence to the Mediterranean Diet and the onset of stroke and cognitive decline, as well as examine stroke severity (ischemic or hemorrhagic) and its association with Mediterranean Diet adherence (MEDAS questionnaire). Additionally, the study will explore the link between diet adherence and cognitive deficits, and measure changes in biological and anthropometric parameters as a result of adopting the Mediterranean Diet. Phase 2 is an interventional dietary study designed to evaluate the effects of the Mediterranean Diet, enriched with either extra virgin olive oil or walnuts, on stroke incidence and cognitive decline in patients with CAA and CADASIL.
Study Type
OBSERVATIONAL
Enrollment
86
participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil
participants in this group will follow a Mediterranean Diet enriched with walnuts
participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
RECRUITINGIncidence of Stroke
evaluation of the incidence of stroke (ischemic and hemorrhagic) in patients following the Mediterranean Diet (with olive oil or walnuts) compared to a low-fat control diet. The incidence of stroke (ischemic and hemorrhagic) will be assessed through clinical diagnosis, based on medical records and confirmed by neuroimaging techniques (e.g., MRI, CT scans). Stroke type (ischemic or hemorrhagic) will be classified based on neuroimaging results and clinical evaluation.
Time frame: Throughout the study, from baseline to the end of the study (12 months or as specified).
Cognitive Decline
Cognitive decline will be assessed using the Montreal Cognitive Assessment (MoCA), a standardized neuropsychological test. The MoCA scale ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores suggesting greater cognitive impairment. The MoCA score is corrected for the patient's age and education level. A corrected score below 18.59 indicates cognitive impairment below the normal range. A score between 18.59 and 20.69 suggests the patient is within the lower limits of the normal range, while a score above 20.69 indicates a score above the normal range, according to Italian reference norms. The test will be administered by a trained neuropsychologist
Time frame: Throughout the study, from baseline to the end of the study (12 months or as specified).
Adherence to Mediterranean Diet
Adherence to Mediterranean Diet is assessed using Mediterranean Diet Adherence Screener (MEDAS), a validated 14-item questionnaire. A total MEDAS score is calculated by summing the points from all items, obtaining a score ranging from 0 to 14. Subjects with scores above 9 are classified as having high adherence to the MD, those scoring between 6 and 8 have moderate adherence, and scores below 6 indicate low adherence.
Time frame: Baseline, 6 months, and 12 months
Nutritional Status
Physical activity level is assessed using the validated 7-item International Physical Activity Questionnaire (IPAQ), which evaluates activity over the past 7 days. Activity volume is calculated by weighting each activity type according to its energy expenditure, expressed in metabolic equivalents (METs), and the total daily METs for each patient is determined. Mini Nutritional Assessment (MNA) is used to identify malnourished patients or those at risk of malnutrition in elderly individuals in clinics, hospitals and nursing homes. MNA is a validated test of 18 multiple choice questions divided into two parts. A final score which indicates the level of the risk of malnutrition (low, medium or high), is obtained. A score between 24-30 indicates an adequate nutritional status, 17-23.5 shows a risk of malnutrition and a value \< 17 is an indicator of malnutrition or poor nutritional status
Time frame: Baseline and 12 months.
Body Composition (Lean and Fat Mass)
Anthropometric measurements are collected according to the conventional criteria and measuring procedures proposed by Lohman. All patients undergo the following anthropometrics measurements: body weight (kg), body height (cm), body circumference (cm) and skinfold thickness (mm). Each skinfold thickness is measured 3 times and the mean value is calculated. Body density and fat mass are calculated using the Durnin and Womersley method and by Siri formula, respectively. Fat mass is then converted to kilograms, which allows for the estimation of fat-free mass in kilograms. All the measurements are performed on the non-dominant side of the body
Time frame: Baseline and 12 months.
Basal Metabolism and Total Energy Expenditure
Through METs calculations, the physical activity level is estimated, enabling the estimation of total daily energy expenditure (TDEE) using the basal metabolic rate (BMR) determined by Harris-Benedict formula.
Time frame: Baseline and 12 months.
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