Actively Recruiting
Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2025-04-18
86
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals of any sex aged 18 years or older
- Diagnosis of CADASIL confirmed genetically by NOTCH3 gene mutation
- Diagnosis of possible or probable Cerebral Amyloid Angiopathy (CAA) based on Boston 2.0 criteria
- Provide informed consent for use of demographic, clinical, and nutritional data anonymously for scientific purposes
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Actively Recruiting
Research Team
A
Anna Bersano, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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