Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.

Condition(s) studied

Investigational drug(s) / intervention(s)

Mediterranean Diet with Extra Virgin Olive Oil: participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil

Mediterranean Diet with Walnuts: participants in this group will follow a Mediterranean Diet enriched with walnuts

Low-Fat Control Diet: participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence of Stroke — Throughout the study, from baseline to the end of the study (12 months or as specified).
  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.
• Cognitive Decline — Throughout the study, from baseline to the end of the study (12 months or as specified).
  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

Trial sites (1)

More Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta trials in Italy

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