Parkinson's Research In Metagenomic Early Stage Biomarkers

NCT07097103 | Not Yet Recruiting

• 1 other identifier: RP 340/SR/25
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease (PD)

Keywords

Physical activity; Mediterranean Diet; Pilot study; Microbiome; Parkinson's disease

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

• Beta Diversity of the fecal microbiota

  Changes in fecal microbiota beta diversity, refers to the degree of difference in microbial community composition between different fecal samples, will be assessed.

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

• Enterobacteriaceae species abundance across Parkinson's disease stage

  Changes in fecal microbial composition will be assessed. Specifically, we will measure the relative abundance of Enterobacteriaceae species and pathotypes across different stages of Parkinson's disease.

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

• Fecal Microbial relative quantification

  Changes in relative quantification

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Secondary Outcomes (4)

• Intestinal Inflammation

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

• Intestinal Permeability

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

• Changes in extracellular vesicle concentration (particles/mL) in saliva and plasma will be assessed.

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

• Changes in protein marker expression in saliva and plasma.

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Other Outcomes (19)

• Total score on the Digestion-Associated Quality of Life Questionnaire (DQLQ)

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

• Changes in non-motor symptoms MDS-UPDRS Part I

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

• Changes in motor symptoms MDS-UPDRS Part II

  Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Study Arms (4)

Mediterranean Diet Intervention (Group A)

EXPERIMENTAL

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

Behavioral: Mediterranean Diet Intervention

Intensive Physical Activity Intervention (Group B)

EXPERIMENTAL

Participants engage in a supervised structured physical activity program.

Behavioral: Intensive Physical Activity Intervention

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

EXPERIMENTAL

Participants will receive both dietary and physical activity interventions.

Behavioral: Mediterranean Diet Intervention; Behavioral: Intensive Physical Activity Intervention

Controls (Group D)

ACTIVE COMPARATOR

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

Other: Control

Interventions

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.

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

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.

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

Control 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.

Controls (Group D)

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• San Raffaele Cassino, Cassino, Italy: collaborator

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Alice Fognani

CONTACT

+39 0652253440; alice.fognani@uniroma5.it

Lucia Gatta, PhD

CONTACT

+39 0652253440; lucia.gatta@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It's a 2x2 factorial, randomized, controlled, non-pharmacological intervention pilot study

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 11, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share