Dopaminergic Receptors on CD4+ T Naive and Memory Lymphocytes Correlate with Motor Impairment in Patients with Parkinson's Disease.
Natasa Kustrimovic, Emanuela Rasini, Massimiliano Legnaro...
https://pubmed.ncbi.nlm.nih.gov/27652978Actively Recruiting
Phase Not Applicable
Age: 40Years - 85Years
All Genders
ID06705517
Mediterranean Diet Effects on Parkinson's Disease (MED-PARK): a Randomized Controlled Trial
Led by Università degli Studi dell'Insubria · Updated on 2025-07-11
44
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
Università degli Studi dell'Insubria
Lead Sponsor
A
Associazione Parkinson Insubria (AsPI), Section of Varese
Collaborating Sponsor
AI-Summary
What this Trial Is About
Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms that reduce quality of life. Researchers are studying whether the Mediterranean diet (MD), a plant-based diet rich in vegetables, fruits, whole grains, and healthy fats like olive oil, can improve symptoms and slow disease progression. This randomized controlled trial explores the diet's effects on motor and non-motor symptoms, quality of life, gastrointestinal function, immune system responses, and microbiome composition in PD patients aged 40 to 85. Participants will be randomly assigned to one of two groups: the intervention group will follow a Mediterranean diet for six months with support including a booklet, monthly recipes, and cooking classes involving caregivers; the control group will continue their usual diet and standard care. Both groups will undergo routine assessments at the start and after six months. The study is single-masked and non-pharmacological. During the study, participants will complete questionnaires, provide blood, stool, and urine samples, and undergo evaluations including motor symptom scoring (MDS-UPDRS), non-motor symptom assessment, gastrointestinal symptom rating, quality of life surveys, and measurement of immune and metabolic markers. Researchers will monitor diet adherence and medication use, with the main outcome being patient-reported symptoms after six months. Safety and overall health markers will be tracked throughout the study period.
CONDITIONS
Brief Title
Mediterranean Diet Effects on Parkinson's Disease
Who Can Participate
Age: 40Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with Parkinson's disease according to international guidelines
- Age between 40 and 85 years
- Naive to medication or on stable anti-Parkinson's therapy for at least two weeks
- Hoehn & Yahr stage 3 or lower
- Able to feed independently
- Able to give informed consent
- Willing to maintain usual diet before randomization and if assigned to control group
- Willing to change diet to Mediterranean diet if assigned to intervention group
- Willing to complete questionnaires
- Willing to provide blood and stool samples during study
- Willing to fast at least 12 hours before sample collection
- Willing to stop supplements, probiotics, herbal or high-dose vitamins/minerals that affect inflammation during study
- No medical or social conditions preventing participation in a six-month study
You will not qualify if you...
- Atypical or secondary parkinsonism
- Underweight (BMI less than 18.5)
- Obesity (BMI greater than 30)
- Pregnancy or suspected pregnancy
- Need for assisted or enteral nutrition
- Chronic autoimmune diseases
- Use of immunosuppressive drugs within past year
- Use of cytotoxic cancer drugs within past year
- Major abdominal surgery history
- Participation in other interventional studies
- Intentional diet change after Parkinson's diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 6 months
Participants in the intervention group will follow a Mediterranean Diet program for six months, including receiving educational materials, monthly recipes, and optional cooking classes with caregiver involvement. Participants in the control group will maintain their usual diet and standard care.
Baseline visit and monthly follow-up visits
Follow-up
Duration - 6 months
Participants undergo assessments to monitor symptom progression, immune function, microbiota, metabolomics, and quality of life over the six-month study period.
Visits coincide with treatment period assessments at baseline and monthly intervals
Trial Site Locations
Total: 1 location
1
Centre for Research in Medical Pharmacology
Varese, Varese, Italy, 21100
Actively Recruiting
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Research Team
M
Marco Cosentino, MD, PhD
F
Franca Marino, M.Sc., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Parkinson's disease patients have a complex phenotypic and functional Th1 bias: cross-sectional studies of CD4+ Th1/Th2/T17 and Treg in drug-naïve and drug-treated patients.
Natasa Kustrimovic, Cristoforo Comi, Luca Magistrelli...
https://pubmed.ncbi.nlm.nih.gov/30001736Modified Mediterranean diet effects on Parkinson's disease (MED-PARK): a single-centre randomised controlled trial protocol.
Elenamaria Pirovano, Franca Marino, Elena Rossi...
https://pubmed.ncbi.nlm.nih.gov/41047258