Cerebral Amyloid AngiopathyDIETETICANCT06933212
Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
An observational study of Cerebral Amyloid Angiopathy and CAA - Cerebral Amyloid Angiopathy, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy, CAA - Cerebral Amyloid Angiopathy
- What is being tested?
- Mediterranean Diet with Extra Virgin Olive Oil and Mediterranean Diet with Walnuts
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2024to 31 Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- na
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Anna Bersano, MD, 02 2394.3062 ext. 3062, anna.bersano@istituto-besta.it
About this study
Official title: Effetto Della DIETa mEdiTerranea Sull'Incidenza di Ictus e Sul Decadimento Cognitivo in Pazienti Affetti da Cadasil e Angiopatia Cerebrale Amiloide
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.
- Being tested
- Mediterranean Diet with Extra Virgin Olive Oil, Mediterranean Diet with Walnuts, Low-Fat Control Diet
- Keywords
- CADASIL, CAA, Mediterranean Diet, Nutritional status, Cognitive decline, Stroke incidence
- Medical subject headings
- Cerebral Amyloid Angiopathy, Cerebral Amyloid Angiopathy, Familial, CADASIL, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet with Extra Virgin Olive OilOther
participants in this group will follow a Mediterranean Diet enriched with extra virgin olive oil
Mediterranean Diet with WalnutsOther
participants in this group will follow a Mediterranean Diet enriched with walnuts
Low-Fat Control DietOther
participants in this group will follow a low-fat control diet as a comparison to the Mediterranean Diet groups
| Study group | Role | What they receive |
|---|---|---|
| CADASIL | Not described Receives: Other: Mediterranean Diet with Extra Virgin Olive Oil; Other: Mediterranean Diet with Walnuts; Other: Low-Fat Control Diet | |
| CAA patients | Not described Receives: Other: Mediterranean Diet with Extra Virgin Olive Oil; Other: Mediterranean Diet with Walnuts; Other: Low-Fat Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Throughout the study, from baseline to the end of the study (12 months or as specified).
Secondary outcomes (4)
Adherence to Mediterranean Diet
Adherence to Mediterranean Diet is assessed using Mediterranean Diet Adherence Screener (MEDAS), a validated 14-item questionnaire. A total MEDAS score is calculated by summing the points from all items, obtaining a score ranging from 0 to 14. Subjects with scores above 9 are classified as having high adherence to the MD, those scoring between 6 and 8 have moderate adherence, and scores below 6 indicate low adherence.
Measured: Baseline, 6 months, and 12 months
Nutritional Status
Physical activity level is assessed using the validated 7-item International Physical Activity Questionnaire (IPAQ), which evaluates activity over the past 7 days. Activity volume is calculated by weighting each activity type according to its energy expenditure, expressed in metabolic equivalents (METs), and the total daily METs for each patient is determined. Mini Nutritional Assessment (MNA) is used to identify malnourished patients or those at risk of malnutrition in elderly individuals in clinics, hospitals and nursing homes. MNA is a validated test of 18 multiple choice questions divided into two parts. A final score which indicates the level of the risk of malnutrition (low, medium or high), is obtained. A score between 24-30 indicates an adequate nutritional status, 17-23.5 shows a risk of malnutrition and a value < 17 is an indicator of malnutrition or poor nutritional status
Measured: Baseline and 12 months.
Body Composition (Lean and Fat Mass)
Anthropometric measurements are collected according to the conventional criteria and measuring procedures proposed by Lohman. All patients undergo the following anthropometrics measurements: body weight (kg), body height (cm), body circumference (cm) and skinfold thickness (mm). Each skinfold thickness is measured 3 times and the mean value is calculated. Body density and fat mass are calculated using the Durnin and Womersley method and by Siri formula, respectively. Fat mass is then converted to kilograms, which allows for the estimation of fat-free mass in kilograms. All the measurements are performed on the non-dominant side of the body
Measured: Baseline and 12 months.
Basal Metabolism and Total Energy Expenditure
Through METs calculations, the physical activity level is estimated, enabling the estimation of total daily energy expenditure (TDEE) using the basal metabolic rate (BMR) determined by Harris-Benedict formula.
Measured: Baseline and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start10 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933212
- Sponsor's protocol ID
- DIETETICA
- Acronym
- DIETETICA
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31383501Tuttolomondo 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.
PubMed 31547615Misirli 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.
PubMed 23186748Tuttolomondo 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.
PubMed 26409625Feart 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.
PubMed 23228285Shannon 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.
PubMed 36915130Roman 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.
PubMed 31521398Lin 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.
PubMed 27412896Biffi 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.
PubMed 21519520Buffon 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.
PubMed 16421118Ruchoux MM, Maurage CA. CADASIL: Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy. J Neuropathol Exp Neurol. 1997 Sep;56(9):947-64.
PubMed 9291937Chabriat 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.
PubMed 19539236