Mediterranean diet improves nutritional status
- Trial ID
- NCT07187739
- Official Title
- Investigation of the Effect of the Mediterranean Diet on Nutritional Status in Parkinson's Patients Undergoing Bilateral Subthalamic Nucleus Deep Brain Stimulation
- Goal
- Mediterranean diet improves nutritional status
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Ankara University
- Study Type
- INTERVENTIONAL
- Enrollment
- 24 participants
- Conditions
- Parkinson Disease, Deep Brain Stimulation, Deep Brain Stimulation Surgery
- Interventions
- Mediterranean diet
Summary For Families
They want to see if following a Mediterranean diet can improve nutritional status for people with Parkinson's who are having bilateral subthalamic nucleus deep brain stimulation, a time when weight and nutrition often change. The plan is a Mediterranean eating pattern high in fruits, vegetables, whole grains, olive oil, fish and nuts to boost calories, protein, vitamins and anti-inflammatory antioxidants, which may help maintain weight and recovery; the diet itself does not change antiparkinsonian drugs, though timing of protein can affect levodopa absorption and will be managed while patients continue their meds. The trial is looking for men and women aged 45 to 64 who are scheduled for STN DBS, stay on their Parkinson's medications, have a Mini Mental Test score of 24 or higher, and do not have psychiatric illness or another condition needing a special diet.
Locations
- Ankara Etlik City Hospital, Ankara, Ankara, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Mediterranean diet. They want to see if following a Mediterranean diet can improve nutritional status for people with Parkinson's who are having bilateral subthalamic nucleus deep brain stimulation, a time when weight and nutrition often change. The plan is a Mediterranean eating pattern high in fruits, vegetables, whole grains, olive oil, fish and nuts to boost calories, protein, vitamins and anti-inflammatory antioxidants, which may help maintain weight and recovery; the diet itself does not change antiparkinsonian drugs, though timing of protein can affect levodopa absorption and will be managed while patients continue their meds. The trial is looking for men and women aged 45 to 64 who are scheduled for STN DBS, stay on their Parkinson's medications, have a Mini Mental Test score of 24 or higher, and do not have psychiatric illness or another condition needing a special diet.
- Who can participate?
- Participants must be between 45 Years and 64 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 5 months.
- 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.