Mediterranean diet for people with Parkinson's disease

Mediterranean Diet Effects on Parkinson's Disease (MED-PARK): a Randomized Controlled Trial

This study will try a Mediterranean diet to see if it helps motor and non-motor symptoms in people with Parkinson's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Università degli Studi dell'Insubria (Academic / other)
• Locations: 1 site (Varese, Varese)
• Trial ID: NCT06705517 on ClinicalTrials.gov

What this trial studies

This randomized, controlled, masked, single-center trial assigns participants to either a Mediterranean diet intervention or continuation of their usual diet in two parallel groups. Eligible participants are adults aged 40–85 with idiopathic Parkinson's disease at Hoehn & Yahr stage ≤3 who can feed themselves and provide informed consent. The study measures changes in motor and non-motor symptom scores, quality of life, gastrointestinal symptoms, adaptive immune markers, nasal and fecal microbiome composition, and fecal and urinary metabolomics at baseline and follow-up visits. Diet adherence and safety will be monitored and biological samples collected at defined timepoints.

Who should consider this trial

Good fit: Ideal candidates are people aged 40–85 with idiopathic Parkinson's disease (Hoehn & Yahr stage ≤3) who can eat independently, are stable on Parkinson's medications or drug-naive, and are willing to follow diet instructions and provide biological samples.

Not a fit: Patients with more advanced disease (Hoehn & Yahr >3), those unable to feed themselves, or those unwilling to change their diet, stop supplements/probiotics as required, or provide required samples are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the Mediterranean diet could improve symptoms and quality of life and potentially slow disease progression in people with Parkinson's disease.

How similar studies have performed: Observational studies have linked Mediterranean-style diets to slower progression and better symptom control in Parkinson's, but few randomized interventional trials have tested this approach directly.

Eligibility criteria

Inclusion Criteria:

1. PD diagnosis according to international guidelines;
2. Age between 40 and 85 years;
3. Naive to medication or with a stable dosage of anti-Parkinson's therapy for at least two weeks;
4. Hoehn \& Yahr stage ≤3;
5. Normal independent feeding;
6. Ability to complete informed consent;
7. Willingness to maintain the usual diet in the period between T0 and T1;
8. Willingness to maintain the usual diet if randomized to the control group in the T1-T2 period;
9. Willingness to make changes in their diet to follow a Mediterranean diet if randomized to the intervention group in the T1-T2 period;
10. Willingness to fill out questionnaires;
11. Willingness to provide blood samples during the study collection periods;
12. Willingness to provide stool samples during the study collection periods;
13. Willingness to fast (without food or drink except water, tea or coffee) at least 12 hours before each sample collection;
14. 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;
15. No medical and/or social conditions that could interfere with participation in a six-month interventional study.

Exclusion Criteria:

1. Atypical or secondary parkinsonism;
2. Underweight (\<18.5);
3. Obesity (BMI\>30);
4. Pregnancy or suspected pregnancy;
5. Normal assisted nutrition;
6. Enteral nutrition;
7. Chronic autoimmune diseases;
8. Chronic use of immunosuppressive drugs in the past year;
9. Chronic use of cytotoxic cancer drugs in the past year;
10. Major abdominal surgeries;
11. Concurrent participation in other interventional studies;
12. Intentional change in diet after PD diagnosis.

Where this trial is running

Varese, Varese

• Centre for Research in Medical Pharmacology — Varese, Varese, Italy (Recruiting)

Study contacts

• Principal investigator: Marco Cosentino, MD, PhD — Università degli studi dell Insubria
• Study coordinator: Marco Cosentino, MD, PhD

Conditions Parkinson; Parkinson Disease; Parkinson Disease, Idiopathic; PARKINSON DISEASE; Diet; Mediterranean Diet; Parkinson disease; MIND diet