Taking people in ItalyNo phase

Tests a Mediterranean diet for symptoms in Parkinson's disease

Tests whether a Mediterranean diet eases symptoms in people with Parkinson's disease.

Key facts

Who runs it: Università degli Studi dell'Insubria
Where: Varese, ItalySee the site
Trial code: NCT06705517
Registry title: Mediterranean Diet Effects on Parkinson's Disease
Status: Recruiting
People taking part: 44 people, planned
Started: 17 Jan 2025
Planned end: Sept 2026
Type of study: Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested: Mediterranean Diet
Record updated: 11 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Parkinson's disease who are willing to keep their usual diet or switch to a Mediterranean diet for six months.

Age: 40 to 85 years
Sex: All sexes can join.
Disease stage: Parkinson's disease diagnosed by international guidelines, Hoehn & Yahr stage 3 or lower.
Earlier treatment: Either never took Parkinson's medicine, or on a stable dose of anti-Parkinson's therapy for at least two weeks. No diet change on purpose since the Parkinson's diagnosis.

Main reasons for not taking part

Atypical or secondary parkinsonism
Underweight (below 18.5) or obesity (BMI above 30)
Pregnancy or suspected pregnancy
Chronic autoimmune disease, or chronic use of immunosuppressive or cytotoxic cancer drugs in the past year
Major abdominal surgery

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 40 and 85 years old?

Where in Italy

Centre for Research in Medical PharmacologyVarese, ItalyContact: Marco Cosentino, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

Intervention group (standard of care + MD)Treatment being tested
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.
Treatment: Mediterranean Diet
Control group (standard of care)No study treatment, for comparison
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.