Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
NCT ID: NCT06933212
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
86 participants
OBSERVATIONAL
2024-10-10
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CADASIL
Mediterranean Diet with Extra Virgin Olive Oil
participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil
Mediterranean Diet with Walnuts
participants in this group will follow a Mediterranean Diet enriched with walnuts
Low-Fat Control Diet
participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups
CAA patients
Mediterranean Diet with Extra Virgin Olive Oil
participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil
Mediterranean Diet with Walnuts
participants in this group will follow a Mediterranean Diet enriched with walnuts
Low-Fat Control Diet
participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups
Interventions
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Mediterranean Diet with Extra Virgin Olive Oil
participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil
Mediterranean Diet with Walnuts
participants in this group will follow a Mediterranean Diet enriched with walnuts
Low-Fat Control Diet
participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
OTHER
Responsible Party
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Locations
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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):260-7. doi: 10.1016/j.atherosclerosis.2015.09.017. Epub 2015 Sep 11.
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.
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.
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.
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.
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.
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.
Ruchoux MM, Maurage CA. CADASIL: Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy. J Neuropathol Exp Neurol. 1997 Sep;56(9):947-64.
Chabriat H, Joutel A, Dichgans M, Tournier-Lasserve E, Bousser MG. Cadasil. Lancet Neurol. 2009 Jul;8(7):643-53. doi: 10.1016/S1474-4422(09)70127-9.
Other Identifiers
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DIETETICA
Identifier Type: -
Identifier Source: org_study_id
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