Parkinson's Research In Metagenomic Early Stage Biomarkers (PRIME_2025)

IRCCS San Raffaele Roma

Status: Not yet enrolling

Conditions: Parkinson's Disease (PD)

Treatments: Other: Control; Behavioral: Intensive Physical Activity Intervention; Behavioral: Mediterranean Diet Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07097103

RP 340/SR/25

Details and patient eligibility

About

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.

Full description

The study will last 60 months, and the following activities are planned:

• Study presentation, selection and enrollment of patients;
• Evaluation of patients' health and nutritional status, including collection of physiological, pathological, and pharmacological history;
• Randomization of patients into four groups;
• Sample collection and storage;
• Microbiome analysis;
• Evaluation of motor and non-motor symptoms using clinical tests and rating scales at baseline (T0), at six months (T1) after treatment initiation, and at three and six months post-intervention (FU1 and FU2, respectively).

Enrollment: 80 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Mediterranean Diet Intervention (Group A)

Experimental group

Description:

Participants receive a structured Mediterranean Diet intervention, including personalized counseling, meal plans, educational sessions and monitoring.

Treatment:

Behavioral: Mediterranean Diet Intervention

Intensive Physical Activity Intervention (Group B)

Experimental group

Description:

Participants engage in a supervised structured physical activity program.

Treatment:

Behavioral: Intensive Physical Activity Intervention

Mediterranean Diet + Intensive Physical Activity Combined Intervention (Group C=A+B)

Experimental group

Description:

Participants will receive both dietary and physical activity interventions.

Treatment:

Behavioral: Mediterranean Diet Intervention

Behavioral: Intensive Physical Activity Intervention

Controls (Group D)

Active Comparator group

Description:

Participants continue their usual Parkinson's disease treatments according to clinical guidelines, without any additional specific dietary or exercise interventions provided by the study.

Treatment:

Other: Control