Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06933212

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet with Extra Virgin Olive Oil

Other

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

Mediterranean Diet with Walnuts

Other

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

Low-Fat Control Diet

Other

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Bersano, MD

CONTACT

[email protected]

02 2394.3062

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: DIETETICA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.