Mediterranean diet for people with Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: marco.cosentino@uninsubria.it
• Phone: 0332217427

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.