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

April 11, 2025 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milano, Italy
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CADASIL
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
CAA patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Stroke
Time Frame: Throughout the study, from baseline to the end of the study (12 months or as specified).
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
Time Frame: Throughout the study, from baseline to the end of the study (12 months or as specified).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Mediterranean Diet
Time Frame: Baseline, 6 months, and 12 months
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.
Baseline, 6 months, and 12 months
Nutritional Status
Time Frame: Baseline and 12 months.
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
Baseline and 12 months.
Body Composition (Lean and Fat Mass)
Time Frame: Baseline and 12 months.
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
Baseline and 12 months.
Basal Metabolism and Total Energy Expenditure
Time Frame: Baseline and 12 months.
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.
Baseline and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Actual)

March 31, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIETETICA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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