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

Last updated: April 11, 2025
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Alzheimer's Disease

Treatment

Mediterranean Diet with Extra Virgin Olive Oil

Low-Fat Control Diet

Mediterranean Diet with Walnuts

Clinical Study ID

NCT06933212
DIETETICA
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • The study will include individuals of both sexes aged 18 years or older with adiagnosis of CADASIL (confirmed genetically by the presence of the NOTCH3 genemutation) 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

Exclusion Criteria:

  • na

Study Design

Total Participants: 86
Treatment Group(s): 3
Primary Treatment: Mediterranean Diet with Extra Virgin Olive Oil
Phase:
Study Start date:
October 10, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milano,
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.