RecruitingNCT06933212

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


Sponsor

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

Enrollment

86 participants

Start Date

Oct 10, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria1

  • na

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Interventions

OTHERMediterranean Diet with Extra Virgin Olive Oil

participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil

OTHERMediterranean Diet with Walnuts

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

OTHERLow-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

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NCT06933212


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