Mediterranean Diet Effects on Parkinson's Disease

Summary

Currently, there are no disease-modifying treatments for Parkinson's disease (PD), the second most common neurodegenerative disorder worldwide, making it crucial to find interventions that can change the disease's trajectory. Epidemiological studies suggest that the Mediterranean diet (MD) is linked to improved motor and non-motor symptoms, slower disease progression, and lower mortality in PD patients. However, few interventional studies have explored this connection. This study assesses whether an MD can improve motor and non-motor symptoms in PD patients. Additionally, the study will examine the effects of the diet on a patient's quality of life, gastrointestinal symptomatology, adaptive immune system, fecal and nasal microbiome, and fecal and urinary metabolomics.

This is a randomized, controlled, non-pharmacological, single-center, masked trial with two parallel groups. It will evaluate the safety and efficacy of the MD on motor and non-motor symptoms reported by PD patients. Forty-four participants, aged 40-85, meeting the inclusion criteria will be enrolled and block-randomized into two groups: one maintaining their usual diet (control) and the other following a MD for six months (intervention).

The primary outcome is patient-reported symptoms, measured using the MDS-UPDRS I+II score.

Secondary outcomes include the analysis of adaptive immune system cells, nasal and fecal microbiome composition, and inflammatory and metabolic markers. Additional assessments include disease severity (MDS-UPDRS), non-motor symptoms (Non-Motor Symptoms Scale), participant well-being (36-Item Short Form Health Survey), gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale and Patient Assessment of Constipation Quality of Life), and the intensity of dopaminergic therapy (levodopa equivalents). Evaluations will be performed at baseline and after six months.

Conditions

• Parkinson
• Parkinson Disease
• Parkinson Disease, Idiopathic
• PARKINSON DISEASE (Disorder)

Interventions

BEHAVIORAL

Mediterranean Diet

The MD emphasizes a plant-based approach, with a high consumption of vegetables, fruits, whole grains, legumes, and nuts, alongside moderate amounts of fish, seafood, and dairy, while limiting meat, particularly red and processed varieties. Olive oil serves as the main fat source in the diet. In the case of this study participants will also be instructed to limit dairy intake, that although traditionally part of the MD, might exacerbate disease symptomatology in PD patients, likely due to the urate lowering effect of dairy.

Sponsors & Collaborators

• Associazione Parkinson Insubria (AsPI), Section of Varese

  collaborator UNKNOWN

• University of Piemonte Orientale

  collaborator UNKNOWN

• Universidade Nova de Lisboa

  collaborator OTHER

• Università degli Studi dell'Insubria

  lead OTHER

Principal Investigators

• Marco Cosentino, MD, PhD · Università degli studi dell Insubria

• Franca Marino, M.Sc., PhD · Università degli studi dell Insubria

• Elenamaria Pirovano, MD · Università degli studi dell Insubria

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-17

Primary Completion

2026-02-28

Completion

2026-09-30

Countries

• Italy

Study Locations