Parkinson's Research In Metagenomic Early Stage Biomarkers

NCT ID: NCT07097103

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-07-31

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).

Conditions

Parkinson's Disease (PD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mediterranean Diet Intervention (Group A)

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

Group Type: EXPERIMENTAL

Mediterranean Diet Intervention

Intervention Type: 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 (Group B)

Participants engage in a supervised structured physical activity program.

Group Type: EXPERIMENTAL

Intensive Physical Activity Intervention

Intervention Type: 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.

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

Participants will receive both dietary and physical activity interventions.

Group Type: EXPERIMENTAL

Mediterranean Diet Intervention

Intervention Type: 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

Intervention Type: 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.

Controls (Group D)

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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.

Interventions

Mediterranean Diet Intervention

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.

Intervention Type: BEHAVIORAL

Intensive Physical Activity Intervention

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.

Intervention Type: BEHAVIORAL

Control

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Raffaele Cassino, Cassino, Italy

UNKNOWN

Sponsor Role: collaborator

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alice Fognani

Role: CONTACT

alice.fognani@uniroma5.it

+39 0652253440

Lucia Gatta, PhD

Role: CONTACT

lucia.gatta@sanraffaele.it

+39 0652253440

Other Identifiers

RP 340/SR/25

Identifier Type: -

Identifier Source: org_study_id