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

NCT06933212 | Recruiting

• 1 other identifier: DIETETICA
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Amyloid Angiopathy; CAA - Cerebral Amyloid Angiopathy

Keywords

CADASIL; CAA; Mediterranean Diet; Nutritional status; Cognitive decline; Stroke incidence

Outcome Measures

Primary Outcomes (2)

• Incidence of Stroke

  evaluation of the incidence of stroke (ischemic and hemorrhagic) in patients following the Mediterranean Diet (with olive oil or walnuts) compared to a low-fat control diet. The incidence of stroke (ischemic and hemorrhagic) will be assessed through clinical diagnosis, based on medical records and confirmed by neuroimaging techniques (e.g., MRI, CT scans). Stroke type (ischemic or hemorrhagic) will be classified based on neuroimaging results and clinical evaluation.

  Throughout the study, from baseline to the end of the study (12 months or as specified).

• Cognitive Decline

  Cognitive decline will be assessed using the Montreal Cognitive Assessment (MoCA), a standardized neuropsychological test. The MoCA scale ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores suggesting greater cognitive impairment. The MoCA score is corrected for the patient's age and education level. A corrected score below 18.59 indicates cognitive impairment below the normal range. A score between 18.59 and 20.69 suggests the patient is within the lower limits of the normal range, while a score above 20.69 indicates a score above the normal range, according to Italian reference norms. The test will be administered by a trained neuropsychologist

  Throughout the study, from baseline to the end of the study (12 months or as specified).

Secondary Outcomes (4)

• Adherence to Mediterranean Diet

  Baseline, 6 months, and 12 months

• Nutritional Status

  Baseline and 12 months.

• Body Composition (Lean and Fat Mass)

  Baseline and 12 months.

• Basal Metabolism and Total Energy Expenditure

  Baseline and 12 months.

Study Arms (2)

CADASIL

Other: Mediterranean Diet with Extra Virgin Olive Oil; Other: Mediterranean Diet with Walnuts; Other: Low-Fat Control Diet

CAA patients

Other: Mediterranean Diet with Extra Virgin Olive Oil; Other: Mediterranean Diet with Walnuts; Other: Low-Fat Control Diet

Interventions

Mediterranean Diet with Extra Virgin Olive Oil OTHER

participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil

CAA patients; CADASIL

Mediterranean Diet with Walnuts OTHER

participants in this group will follow a Mediterranean Diet enriched with walnuts

CAA patients; CADASIL

Low-Fat Control Diet OTHER

participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups

CAA patients; CADASIL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 26409625 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 36915130 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21519520 BACKGROUND

• 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.

  PMID: 16421118 BACKGROUND

• Ruchoux MM, Maurage CA. CADASIL: Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy. J Neuropathol Exp Neurol. 1997 Sep;56(9):947-64.

  PMID: 9291937 BACKGROUND

• 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.

  PMID: 19539236 BACKGROUND

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; CADASIL; Cognitive Dysfunction

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Cerebral Small Vessel Diseases; Amyloidosis, Familial; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebral Infarction; Brain Infarction; Brain Ischemia; Dementia, Vascular; Stroke; Dementia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Anna Bersano, MD

CONTACT

02 2394.3062; anna.bersano@istituto-besta.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 18, 2025
• Study Start: October 10, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)