Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mediterranean Diet with Extra Virgin Olive Oil, Mediterranean Diet with Walnuts, Low-Fat Control Diet.
- Who it may be relevant to
- Registry conditions: Cerebral Amyloid Angiopathy, CAA - Cerebral Amyloid Angiopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effetto Della DIETa mEdiTerranea Sull'Incidenza di Ictus e Sul Decadimento Cognitivo in Pazienti Affetti da Cadasil e Angiopatia Cerebrale Amiloide
Overview
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.
Interventions
- Other Mediterranean Diet with Extra Virgin Olive Oil
participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil - Other Mediterranean Diet with Walnuts
participants in this group will follow a Mediterranean Diet enriched with walnuts - Other Low-Fat Control Diet
participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups
Primary outcome measures
- Incidence of Stroke [Time frame: Throughout the study, from baseline to the end of the study (12 months or as specified).]
- Cognitive Decline [Time frame: Throughout the study, from baseline to the end of the study (12 months or as specified).]
Secondary outcome measures (4)
- Adherence to Mediterranean Diet [Time frame: Baseline, 6 months, and 12 months]
- Nutritional Status [Time frame: Baseline and 12 months.]
- Body Composition (Lean and Fat Mass) [Time frame: Baseline and 12 months.]
- Basal Metabolism and Total Energy Expenditure [Time frame: Baseline and 12 months.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
Publications
- 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. PMID 31383501
- Tuttolomondo A, Simonetta I, Daidone M, Mogavero A, Ortello A, Pinto A. Metabolic and Vascular Effect of the Mediterranean Diet. Int J Mol Sci. 2019 Sep 23;20(19):4716. doi: 10.3390/ijms20194716. PMID 31547615
- Misirli G, Benetou V, Lagiou P, Bamia C, Trichopoulos D, Trichopoulou A. Relation of the traditional Mediterranean diet to cerebrovascular disease in a Mediterranean population. Am J Epidemiol. 2012 Dec 15;176(12):1185-92. doi: 10.1093/aje/kws205. Epub 2012 Nov 27. PMID 23186748
- Tuttolomondo A, Casuccio A, Butta C, Pecoraro R, Di Raimondo D, Della Corte V, Arnao V, Clemente G, Maida C, Simonetta I, Miceli G, Lucifora B, Cirrincione A, Di Bona D, Corpora F, Maugeri R, Iacopino DG, Pinto A. Mediterranean Diet in patients with acute ischemic stroke: Relationships between Mediterranean Diet score, diagnostic subtype, and stroke severity index. Atherosclerosis. 2015 Nov;243(1) PMID 26409625
- Feart C, Samieri C, Alles B, Barberger-Gateau P. Potential benefits of adherence to the Mediterranean diet on cognitive health. Proc Nutr Soc. 2013 Feb;72(1):140-52. doi: 10.1017/S0029665112002959. Epub 2012 Dec 11. PMID 23228285
- 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 Ma PMID 36915130
- 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. PMID 31521398
- 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. PMID 27412896
Identifiers
NCT: NCT06933212 · DIETETICA