Mediterranean diet slows Parkinson progression
- Trial ID
- NCT06705517
- Official Title
- Mediterranean Diet Effects on Parkinson's Disease (MED-PARK): a Randomized Controlled Trial
- Goal
- Mediterranean diet slows Parkinson progression
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Università degli Studi dell'Insubria
- Study Type
- INTERVENTIONAL
- Enrollment
- 44 participants
- Conditions
- Parkinson, Parkinson Disease, Parkinson Disease, Idiopathic, PARKINSON DISEASE (Disorder)
- Interventions
- Mediterranean Diet
Summary For Families
Aiming to see whether switching to a Mediterranean diet can ease symptoms or slow progression in Parkinson's by lowering inflammation and shifting the gut microbiome, both of which may affect motor and non-motor problems. Participants randomized to the Mediterranean diet will eat more vegetables, fruits, whole grains, legumes, fish and olive oil and less red and processed meat, and researchers will track clinical measures plus blood and stool markers to link those dietary changes to Parkinson's signs; the diet is tested alongside usual Parkinson's medications, not as a replacement. The trial is looking for people 40 to 85 with idiopathic Parkinson's at Hoehn and Yahr stage 3 or lower, who can eat independently, are willing to follow the diet and give blood and stool samples, and who are either medication-naive or on a stable anti-Parkinson's dose; underweight, obese, certain immune conditions, and recent immune-suppressing treatments are excluded.
Locations
- Centre for Research in Medical Pharmacology, Varese, Varese, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Mediterranean Diet. Aiming to see whether switching to a Mediterranean diet can ease symptoms or slow progression in Parkinson's by lowering inflammation and shifting the gut microbiome, both of which may affect motor and non-motor problems. Participants randomized to the Mediterranean diet will eat more vegetables, fruits, whole grains, legumes, fish and olive oil and less red and processed meat, and researchers will track clinical measures plus blood and stool markers to link those dietary changes to Parkinson's signs; the diet is tested alongside usual Parkinson's medications, not as a replacement. The trial is looking for people 40 to 85 with idiopathic Parkinson's at Hoehn and Yahr stage 3 or lower, who can eat independently, are willing to follow the diet and give blood and stool samples, and who are either medication-naive or on a stable anti-Parkinson's dose; underweight, obese, certain immune conditions, and recent immune-suppressing treatments are excluded.
- Who can participate?
- Participants must be between 40 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.