Mediterranean Diet Effects on Parkinson's Disease

NCT06705517 | Recruiting DMC

• 1 other identifier: MED-PARK
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Diet; Mediterranean Diet; Parkinson; Parkinson disease; MIND diet; plant based diet; unprocessed diet

Outcome Measures

Primary Outcomes (1)

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I+II

  The primary outcome of this study is the mean (final - baseline) change in disease severity between the control and intervention groups at the end of the intervention, which will be assessed using the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I+II score. Part I of the scale (13 items) investigates non-motor aspects of the disease, whilst part II (13 items) refers to motor aspects. The MDS-UPDRS will be performed at baseline and after 6 months. The scores in each item vary from 0 (normal) to 4(severe), Higher the score, the more severe the condition or symptom.

  Baseline - 6 months

Secondary Outcomes (26)

• Immunophenotype

  Baseline - 6 months

• Intestinal and Nasal microbiota

  Baseline - 6 months

• Fecal metabolites

  Baseline - 6 months

• Urinary metabolites

  Baseline - 6 months

• Non-Motor Symptom Scale (NMSS)

  Baseline - 6 months

Study Arms (2)

Intervention group (standard of care + MD)

EXPERIMENTAL

The intervention group will participate in a six-month program aimed at promoting adherence to the MD. At the start, participants will be given a physical booklet outlining foods to prioritize and avoid. They will also receive monthly recipes featuring seasonal ingredients. In addition, cooking classes will be offered, with caregiver involvement encouraged.

Behavioral: Mediterranean Diet

Control group (standard of care)

NO INTERVENTION

The control group will be asked to maintain their current dietary habits and usual standard care. They will undergo the same routine examinations and check-ups as the intervention group.

Interventions

Mediterranean Diet BEHAVIORAL

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.

Also known as: Dietary intervention

Intervention group (standard of care + MD)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PD diagnosis according to international guidelines;
• Age between 40 and 85 years;
• Naive to medication or with a stable dosage of anti-Parkinson's therapy for at least two weeks;
• Hoehn \& Yahr stage ≤3;
• Normal independent feeding;
• Ability to complete informed consent;
• Willingness to maintain the usual diet in the period between T0 and T1;
• Willingness to maintain the usual diet if randomized to the control group in the T1-T2 period;
• Willingness to make changes in their diet to follow a Mediterranean diet if randomized to the intervention group in the T1-T2 period;
• Willingness to fill out questionnaires;
• Willingness to provide blood samples during the study collection periods;
• Willingness to provide stool samples during the study collection periods;
• Willingness to fast (without food or drink except water, tea or coffee) at least 12 hours before each sample collection;
• Willingness to discontinue taking supplements, probiotics, herbal or high- dose vitamins or minerals that could impact inflammation during the period between T0 and T1 and for the duration of the study protocol;
• No medical and/or social conditions that could interfere with participation in a six-month interventional study.

You may not qualify if:

• Atypical or secondary parkinsonism;
• Underweight (\<18.5);
• Obesity (BMI\>30);
• Pregnancy or suspected pregnancy;
• Normal assisted nutrition;
• Enteral nutrition;
• Chronic autoimmune diseases;
• Chronic use of immunosuppressive drugs in the past year;
• Chronic use of cytotoxic cancer drugs in the past year;
• Major abdominal surgeries;
• Concurrent participation in other interventional studies;
• Intentional change in diet after PD diagnosis.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead
• Associazione Parkinson Insubria (AsPI), Section of Varese: collaborator
• University of Piemonte Orientale: collaborator
• Universidade Nova de Lisboa: collaborator

Study Sites (1)

Centre for Research in Medical Pharmacology

Varese, Varese, 21100, Italy

RECRUITING

Related Publications (3)

• Kustrimovic N, Rasini E, Legnaro M, Bombelli R, Aleksic I, Blandini F, Comi C, Mauri M, Minafra B, Riboldazzi G, Sanchez-Guajardo V, Marino F, Cosentino M. Dopaminergic Receptors on CD4+ T Naive and Memory Lymphocytes Correlate with Motor Impairment in Patients with Parkinson's Disease. Sci Rep. 2016 Sep 22;6:33738. doi: 10.1038/srep33738.

  PMID: 27652978 BACKGROUND

• Kustrimovic N, Comi C, Magistrelli L, Rasini E, Legnaro M, Bombelli R, Aleksic I, Blandini F, Minafra B, Riboldazzi G, Sturchio A, Mauri M, Bono G, Marino F, Cosentino M. Parkinson's disease patients have a complex phenotypic and functional Th1 bias: cross-sectional studies of CD4+ Th1/Th2/T17 and Treg in drug-naive and drug-treated patients. J Neuroinflammation. 2018 Jul 12;15(1):205. doi: 10.1186/s12974-018-1248-8.

  PMID: 30001736 BACKGROUND

• Pirovano E, Marino F, Rossi E, Gennari A, Rasini E, Uslenghi M, Figueira I, Iacoviello L, Ferrari M, Cosentino M. Modified Mediterranean diet effects on Parkinson's disease (MED-PARK): a single-centre randomised controlled trial protocol. BMJ Open. 2025 Oct 5;15(10):e101946. doi: 10.1136/bmjopen-2025-101946.

  PMID: 41047258 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Diet, Mediterranean; Diet Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Marco Cosentino, MD, PhD

  Università degli studi dell Insubria

  PRINCIPAL INVESTIGATOR

• Franca Marino, M.Sc., PhD

  Università degli studi dell Insubria

  PRINCIPAL INVESTIGATOR

• Elenamaria Pirovano, MD

  Università degli studi dell Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Cosentino, MD, PhD

CONTACT

0332217427; marco.cosentino@uninsubria.it

Franca Marino, M.Sc., PhD

CONTACT

0332217427; franca.marino@uninsubria.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors, including the study neurologist and researchers analyzing biological samples, will be blinded to the allocation of the patients. Patients will be instructed to keep this information confidential during their neurological evaluations. Before data analysis, the dataset will be anonymized a second time to perform a blind data analysis, so also investigators will be partially blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is an interventional, non-pharmacological, superiority, randomized, controlled, single-center, masked study with two parallel groups.

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 26, 2024
• Study Start: January 17, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the study conclusion and publication of results

Locations

IT (1)