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/31383501Actively Recruiting
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
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
Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Actively Recruiting
A
Anna Bersano, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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