Mediterranean diet for Parkinson's (NCT07187739)
Reduce after surgery weight gain
- 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
- Reduce after surgery weight gain
- 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
The trial is testing whether following a Mediterranean diet for three months after bilateral subthalamic nucleus deep brain stimulation (STN DBS) can help control the weight gain and improve body composition that many people see after this surgery. Participants are randomly assigned to get Mediterranean diet recommendations or to keep their usual eating habits, and researchers will track weight, body composition and measures like waist and neck size, arm size, handgrip strength, appetite, quality of life, physical activity, and food records before surgery and at months 1, 2 and 3 after surgery. Weight gain after this operation often happens because people eat more and move less as motor symptoms improve, and it can be linked with higher levodopa doses and metabolic problems, so the study aims to see if dietary guidance can prevent those issues. The study is enrolling adults 45 to 64 who have had bilateral STN DBS, continue Parkinson's medicines, can consent, and score 24 or higher on a brief thinking test; people with psychiatric illness, low test scores, or other conditions that need a special diet are not eligible.
Locations
- Ankara Etlik City Hospital, Ankara, Ankara, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Mediterranean diet. The trial is testing whether following a Mediterranean diet for three months after bilateral subthalamic nucleus deep brain stimulation (STN DBS) can help control the weight gain and improve body composition that many people see after this surgery. Participants are randomly assigned to get Mediterranean diet recommendations or to keep their usual eating habits, and researchers will track weight, body composition and measures like waist and neck size, arm size, handgrip strength, appetite, quality of life, physical activity, and food records before surgery and at months 1, 2 and 3 after surgery. Weight gain after this operation often happens because people eat more and move less as motor symptoms improve, and it can be linked with higher levodopa doses and metabolic problems, so the study aims to see if dietary guidance can prevent those issues. The study is enrolling adults 45 to 64 who have had bilateral STN DBS, continue Parkinson's medicines, can consent, and score 24 or higher on a brief thinking test; people with psychiatric illness, low test scores, or other conditions that need a special diet are not eligible.
- 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?
- 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 5 months.
- 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?
- You will be evaluated at baseline (pre-operative) and at the 1st, 2nd, and 3rd months after surgery.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.