NCT06933212

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

Effetto Della DIETa mEdiTerranea Sull'Incidenza di Ictus e Sul Decadimento Cognitivo in Pazienti Affetti da Cadasil e Angiopatia Cerebrale Amiloide

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 86 (estimated)
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Amyloid Angiopathy
• CAA - Cerebral Amyloid Angiopathy

Interventions

Type	Name	Description
OTHER	Mediterranean Diet with Extra Virgin Olive Oil	participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil
OTHER	Mediterranean Diet with Walnuts	participants in this group will follow a Mediterranean Diet enriched with walnuts
OTHER	Low-Fat Control Diet	participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-03-31
• Completion: 2026-07-31
• First posted: 2025-04-18
• Last updated: 2025-04-18

Locations

1 site across 1 country: Italy