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Parkinson's Research In Metagenomic Early Stage Biomarkers

Not Yet RecruitingNA

Sponsor: IRCCS San Raffaele Roma

Conditions: Parkinson's Disease (PD)

Interventions: Mediterranean Diet Intervention, Intensive Physical Activity Intervention, Control

Countries: Italy

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 overview

Sex: ALL

Age: 35 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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;
* MMSE ≥24;
* Stable dopaminergic midication regimen for ≥ 4 weeks;
* Ability to interact with the research team and provide informed consent in Italian;
* Suitable to physical exercise;
* Able to walk unassisted (no walking aids);
* Willingness and ability to comply with all study procedures;
* Willingness to maintain usual diet during a ≥ 4-week pre-baseline period;
* Willingness to switch to a Mediterranean-style diet during the intervention;
* Ability to provide stool samples at each collection timepoint;
* Willing to avoid strenuous exercise and alcohol for 24 hours prior to each visits.

Exclusion Criteria:

* Pre-existing psychiatric disorders;
* Atypical or secondary Parkinsonism;
* Presence of pacemakers or other subcutaneous electronic devices;
* Any other neurological or neurodegenerative disorders;
* Moderate to severe cognitive decline;
* Beck Depression Inventory-II (BDI-II)\] score ≥28;
* Dementia diagnosis;
* Thyroid dysfunctions;
* Type1 Diabetes Mellitus;
* Type 2 diabetes mellitus with HbA₁c ≥ 8% or on insulin therapy;
* Acute diseases;
* Active Neoplasia;
* IBD or IBS;
* Celiac disease;
* History of major gastrointestinal surgery or acute GI conditions (e.g., gastroenteritis) within the past 3-6 months;
* Chronic corticosteroid therapy;
* Use of proton pump inhibitors within the past 30 days;
* Acute, antibiotic-resistant infections;
* Antibiotic intake within the past 30 days;
* Prebiotic/probiotic supplement use in the past 30 days;
* Prolonged intake of anxiolytic drugs, antidepressants, antipsychotics, cognitive stimulants, and analogs in the past 3 months;
* Underweight (BMI \<18.5);
* History of deep brain stimulation (DBS) surgery;
* Pregnancy or lactation;
* Regular use of enemas or suppositories to alleviate constipation;
* Use of experimental products in the 3 months prior to the screening visit
* Patients who, for medical reasons, are required to follow special dietary regimens that could interfere with the adoption or effectiveness of the Mediterranean model;
* Vegan/Vegetarian diet or any other dietary behaviour that excludes one or more of the typical food groups of the Mediterranean model.

Locations (2)

Cassino, Frosinone, Italy
Rome, Lazio, Italy