Parkinson's Research In Metagenomic Early Stage Biomarkers

ConditionParkinson's Disease (PD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age35-80

SponsorIRCCS San Raffaele Roma

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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

Mediterranean Diet Intervention
Behavioral
Participants will follow a personalized diet plan over 24 weeks, based on the guidelines of the Mediterranean diet and defined according to their needs and the state of the disease; no food category will be excluded a priori. Individualized nutritional counseling and support materials (weekly meal plans, sample recipes, portion guides) will be provided by a qualified nutritionist. Adherence to the Mediterranean diet will be monitored periodically. Participants will maintain their usual diet during a pre-baseline period of at least 4 weeks, then switch to the Mediterranean plan under the supervision of a nutritionist.
Intensive Physical Activity Intervention
Behavioral
Participants will perform exercise, over 24 weeks, according to WHO recommendations for adults, including those aged ≥ 64 years, to achieve at least 150-300 minutes of moderate-intensity aerobic physical activity, or at least 75-100 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate and vigorous activity during the week. The WHO 2020 also recommend moderate-intensity or greater muscle-strengthening exercises involving alla major muscle groups for 2 or more days per week. Adherence will be monitored during in-person sessions and through wearable devices for activity tracking.
Control
Other intervention
Participants will continue their usual medical management for early Parkinson's disease according to current clinical guidelines, without any additional dietary or exercise interventions provided by the study, and will be monitored through standard follow-up visits but will not receive any study-specific dietary or physical activity programs.

Treatment groups

80 Participants

are divided into 4 treatment groups

Group A: Mediterranean Diet Intervention (Group A)Experimental treatment 1 intervention

Group B: Intensive Physical Activity Intervention (Group B)Experimental treatment 1 intervention

Group C: Mediterranean Diet + Intensive Physical Activity Combined Intervention (Group C=A+B)Experimental treatment 2 interventions

Group D: Controls (Group D)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Alpha Diversity of the fecal microbiota.

Changes in fecal microbiota alpha diversity, a measure of the richness and evenness of microbial species within a sample, will be assessed.

Time frame