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

Recruiting now

Conditions studied: Cerebral Amyloid Angiopathy, CAA - Cerebral Amyloid Angiopathy

In brief

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.

Key facts

Study ID: NCT06933212
Run by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
People needed: 86
Starts: 2024-10-10
Expected to finish: 2026-07-31
Last updated by the study team: 2025-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Where it is running

Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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