ClinicalTrials.gov record NCT06933212

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

Effetto Della DIETa mEdiTerranea Sull'Incidenza di Ictus e Sul Decadimento Cognitivo in Pazienti Affetti da Cadasil e Angiopatia Cerebrale Amiloide

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationItaly
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This study is for people with CADASIL or cerebral amyloid angiopathy (CAA). It has two phases: Phase 1 observes diet, nutritional status, body composition and metabolism and checks how Mediterranean Diet adherence relates to stroke and cognitive function. Phase 2 is a dietary intervention comparing a Mediterranean Diet enriched with extra virgin olive oil or walnuts against a low-fat control diet over about 12 months.

What it is studying. The study is testing whether adherence to the Mediterranean Diet is associated with the incidence and type of stroke (ischemic or hemorrhagic) and with changes in cognitive function. It will also assess nutritional status, body composition, basal metabolism and total energy expenditure, and measure how these parameters change when people follow a Mediterranean Diet enriched with extra virgin olive oil or walnuts compared with a low-fat control diet.

What the researchers hope to learn. Scientifically, the study aims to evaluate associations between Mediterranean Diet adherence and stroke incidence and type, and between diet adherence and cognitive decline; to measure nutritional status, body composition, basal metabolism and total energy expenditure; and to observe changes in these biological and anthropometric parameters after adopting the Mediterranean Diet (with extra virgin olive oil or walnuts) compared with a low-fat diet.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participation lasts up to 12 months and includes an observational phase and, for some participants, a dietary intervention phase where they follow either a Mediterranean diet enriched with extra virgin olive oil, a Mediterranean diet enriched with walnuts, or a low‑fat control diet. At baseline and at follow‑up visits (some measures at 6 and 12 months) participants complete diet and activity questionnaires (MEDAS, IPAQ), a Mini Nutritional Assessment (MNA), and a cognitive test (MoCA) administered by a trained neuropsychologist. Study staff will take body measurements (weight, height, circumferences) and measure skinfold thickness (each measured three times) to estimate body composition, and will calculate basal metabolic rate and total energy expenditure from those data. Stroke occurrence will be assessed from clinical records and neuroimaging results when available; the record does not say whether the study itself performs imaging.

How the study is structured. A prospective cohort study with two phases. Phase 1 is observational: researchers will assess participants' dietary habits and nutritional status, including Mediterranean Diet adherence (MEDAS), body measurements, activity level, and cognitive testing. Phase 2 is an interventional dietary phase in which participants follow either a Mediterranean Diet enriched with extra virgin olive oil, a Mediterranean Diet enriched with walnuts, or a low-fat control diet; outcomes (stroke occurrence and cognitive tests) are tracked from baseline to the study end (about 12 months). The registry does not specify randomization or masking details.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cerebral Amyloid Angiopathy; CAA - Cerebral Amyloid Angiopathy. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 10, 2024
Primary completion
Mar 31, 2025
Study completion
Jul 31, 2027 (estimated)
Target enrollment
86 participants (estimated)
Last updated on registry
Sep 1, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Phase 1
An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Phase 2
A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
interventional
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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