Actively Recruiting

Age: 18Years +
All Genders
ID06933212

Effect of the Mediterranean Diet on Stroke Incidence and Cognitive Decline in Patients with 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

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore the nutritional status and dietary habits of patients with CADASIL and Cerebral Amyloid Angiopathy (CAA). It focuses on how closely these patients follow the Mediterranean Diet and investigates the relationship between this diet adherence and the occurrence of stroke and cognitive decline. The study also examines stroke severity and cognitive deficits in connection with diet adherence, as well as changes in biological and body composition measures related to adopting the Mediterranean Diet. The study has two phases: Phase 1 is observational, assessing diet and nutritional factors in two patient groups with CADASIL and CAA. Phase 2 is an interventional dietary study where participants follow either a Mediterranean Diet enriched with extra virgin olive oil, a Mediterranean Diet enriched with walnuts, or a low-fat control diet. The effects of these diets on stroke incidence and cognitive decline will be evaluated over time. Participants will be monitored at baseline, 6 months, and 12 months for adherence to the Mediterranean Diet, nutritional status, body composition including lean and fat mass, basal metabolism, and total energy use. The main outcomes measured throughout the study are stroke incidence and cognitive decline. The study is led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta and is expected to continue until July 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of CADASIL confirmed by NOTCH3 gene mutation
  • Diagnosis of possible or probable Cerebral Amyloid Angiopathy according to Boston 2.0 criteria
  • Ability to provide informed consent for use of anonymous demographic, clinical, and nutritional data
Not Eligible

You will not qualify if you...

  • na

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 12 months

Participants follow assigned diets and are observed for stroke incidence and cognitive decline while their adherence and nutritional status are assessed.

Visits at baseline, 6 months, and 12 months

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Actively Recruiting

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Research Team

A

Anna Bersano, MD

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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Published Research Related To This Trial

Relationship between adherence to the Mediterranean Diet, intracerebral hemorrhage, and its location.

Antonino Tuttolomondo, Domenico Di Raimondo, Alessandra Casuccio...

https://pubmed.ncbi.nlm.nih.gov/31383501

Mediterranean Diet in patients with acute ischemic stroke: Relationships between Mediterranean Diet score, diagnostic subtype, and stroke severity index.

Antonino Tuttolomondo, Alessandra Casuccio, Carmelo Buttà...

https://pubmed.ncbi.nlm.nih.gov/26409625

Mediterranean diet adherence is associated with lower dementia risk, independent of genetic predisposition: findings from the UK Biobank prospective cohort study.

Oliver M Shannon, Janice M Ranson, Sarah Gregory...

https://pubmed.ncbi.nlm.nih.gov/36915130

Mediterranean diet: The role of long-chain ω-3 fatty acids in fish; polyphenols in fruits, vegetables, cereals, coffee, tea, cacao and wine; probiotics and vitamins in prevention of stroke, age-related cognitive decline, and Alzheimer disease.

G C Román, R E Jackson, R Gadhia...

https://pubmed.ncbi.nlm.nih.gov/31521398

High-Fat-Diet Intake Enhances Cerebral Amyloid Angiopathy and Cognitive Impairment in a Mouse Model of Alzheimer's Disease, Independently of Metabolic Disorders.

Bowen Lin, Yu Hasegawa, Koki Takane...

https://pubmed.ncbi.nlm.nih.gov/27412896