About this trial
This 2x2 factorial, randomized, controlled pilot study aims to identify a specific microbiota pattern, which could constitute a biomarker of Parkinson's disease, and to evaluate whether specific pathotypes can be associated with different stages of the disease; furthermore, the investigators are committed to evaluating how and to what extent the changes induced by a personalized nutritional intervention combined with physical exercise affect the symptoms and quality of life of patients.
Eligibility criteria
Qualifiers
Diagnosis of Parkinson's disease according to United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria;
aged 35-80 years;
Hoehn & Yahr stage > 1 and < 3 in the clinical "ON" state;
MoCA score ≥17.54;
Disqualifiers
Pre-existing psychiatric disorders;
Atypical or secondary Parkinsonism;
Presence of pacemakers or other subcutaneous electronic devices;
Any other neurological or neurodegenerative disorders;
Trial design
Treatments tested in this trial
- Mediterranean Diet Intervention
- Intensive Physical Activity Intervention
- Control
Treatment groups
Locations
Sponsors and collaborators
IRCCS San Raffaele Roma
Lead sponsor
San Raffaele Cassino, Cassino, Italy
Collaborator