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

NCT06933212 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2025-04-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2025-03-31
Completion
2026-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06933212 on ClinicalTrials.gov