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RECRUITING
NCT06933212

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

Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

86

Start Date

2024-10-10

Completion Date

2026-07-31

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

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

Locations (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy