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Recruiting NCT06933212

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

Conditions: Cerebral Amyloid Angiopathy, CAA - Cerebral Amyloid Angiopathy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 86
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Location: Fondazione IRCCS Istituto Neurologico Carlo Besta Milan

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 Criteria

Inclusion Criteria: * The study will include individuals of both sexes aged 18 years or older with a diagnosis of CADASIL (confirmed genetically by the presence of the NOTCH3 gene mutation) or possible/probable CAA (defined according to the Boston 2.0 criteria). All participants must provide informed consent for the use of demographic, clinical, and nutritional data for scientific purposes in an anonymous form Exclusion Criteria: * na

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06933212). StuddyBuddy aggregates publicly available trial information.