Clinical trial NCT06933212: Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
Official title: Effetto Della DIETa mEdiTerranea Sull'Incidenza di Ictus e Sul Decadimento Cognitivo in Pazienti Affetti da Cadasil e Angiopatia Cerebrale Amiloide
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Amyloid Angiopathy
CAA - Cerebral Amyloid Angiopathy
Keywords: CADASIL
CAA
Mediterranean Diet
Nutritional status
Cognitive decline
Stroke incidence
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with CADASIL and CAA who are referred to the outpatient clinics and hospital department of the Complex Structure "Neurology 9 - Cerebrovascular Diseases" at the Fondazione IRCCS Istituto Neurologico "Carlo Besta" in Milan will be enrolled in the study. All patients will be asked to provide their consent to participate in the study by signing a specific form that includes consent for the collection of demographic, clinical, and nutritional data.

Brief 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 Criteria:

* 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 Criteria:

* na

Primary outcomes:
measure: Incidence of Stroke
timeFrame: Throughout the study, from baseline to the end of the study (12 months or as specified).
measure: Cognitive Decline
timeFrame: Throughout the study, from baseline to the end of the study (12 months or as specified).
Secondary outcomes:
measure: Adherence to Mediterranean Diet
timeFrame: Baseline, 6 months, and 12 months
measure: Nutritional Status
timeFrame: Baseline and 12 months.
measure: Body Composition (Lean and Fat Mass)
timeFrame: Baseline and 12 months.
measure: Basal Metabolism and Total Energy Expenditure
timeFrame: Baseline and 12 months.
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
Study officials:
References:
citation: Tuttolomondo A, Di Raimondo D, Casuccio A, Velardo M, Salamone G, Arnao V, Pecoraro R, Della Corte V, Restivo V, Corpora F, Maida C, Simonetta I, Cirrincione A, Vassallo V, Pinto A. Relationship between adherence to the Mediterranean Diet, intracerebral hemorrhage, and its location. Nutr Metab Cardiovasc Dis. 2019 Oct;29(10):1118-1125. doi: 10.1016/j.numecd.2019.06.010. Epub 2019 Jun 20.
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citation: Shannon OM, Ranson JM, Gregory S, Macpherson H, Milte C, Lentjes M, Mulligan A, McEvoy C, Griffiths A, Matu J, Hill TR, Adamson A, Siervo M, Minihane AM, Muniz-Tererra G, Ritchie C, Mathers JC, Llewellyn DJ, Stevenson E. Mediterranean diet adherence is associated with lower dementia risk, independent of genetic predisposition: findings from the UK Biobank prospective cohort study. BMC Med. 2023 Mar 14;21(1):81. doi: 10.1186/s12916-023-02772-3.
citation: Roman GC, Jackson RE, Gadhia R, Roman AN, Reis J. Mediterranean diet: The role of long-chain omega-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. Rev Neurol (Paris). 2019 Dec;175(10):724-741. doi: 10.1016/j.neurol.2019.08.005. Epub 2019 Sep 11.
citation: Lin B, Hasegawa Y, Takane K, Koibuchi N, Cao C, Kim-Mitsuyama S. High-Fat-Diet Intake Enhances Cerebral Amyloid Angiopathy and Cognitive Impairment in a Mouse Model of Alzheimer's Disease, Independently of Metabolic Disorders. J Am Heart Assoc. 2016 Jun 13;5(6):e003154. doi: 10.1161/JAHA.115.003154.
citation: Biffi A, Greenberg SM. Cerebral amyloid angiopathy: a systematic review. J Clin Neurol. 2011 Mar;7(1):1-9. doi: 10.3988/jcn.2011.7.1.1. Epub 2011 Mar 31.
citation: Buffon F, Porcher R, Hernandez K, Kurtz A, Pointeau S, Vahedi K, Bousser MG, Chabriat H. Cognitive profile in CADASIL. J Neurol Neurosurg Psychiatry. 2006 Feb;77(2):175-80. doi: 10.1136/jnnp.2005.068726.
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