Mediterranean Diet for Parkinson's (NCT06705517)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Evaluations are performed at baseline and after six months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.