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ClinicalTrials.gov ID

NCT07097103

Lead Sponsor

IRCCS San Raffaele RomaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Jul 30, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Jul 11, 2029Estimated

Completion Date

Jul 31, 2029Estimated

Official Title

A 2x2 Factorial Randomized Controlled Non-pharmacological Interventional Multicenter Pilot Study on the Influence of the Mediterranean Diet and Physical Exercise on the Microbiome of Patients With Parkinson's Disease

Brief Summary

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.

Detailed 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).

• Parkinson's Disease (PD)

• Mediterranean Diet Intervention
• Intensive Physical Activity Intervention
• Control

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Factorial Assignment

Masking

None (Open Label)

Lead Sponsor

IRCCS San Raffaele RomaOTHER

Collaborators

San Raffaele Telematic UniversityOTHER

University of Urbino "Carlo Bo"OTHER

Northwestern UniversityOTHER

fabrizio.stocchi@sanraffaele.it0652252311 ext. 0039