ESPEN guideline clinical nutrition in neurology.
Rosa Burgos, Irene Bretón, Emanuele Cereda...
https://pubmed.ncbi.nlm.nih.gov/29274834Actively Recruiting
Phase Not Applicable
Age: 45Years - 64Years
All Genders
ID07187739
Investigation of the Effect of the Mediterranean Diet on Nutritional Status in Parkinson's Patients Undergoing Bilateral Subthalamic Nucleus Deep Brain Stimulation
Led by Ankara University · Updated on 2025-12-03
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether following a Mediterranean diet can help manage body weight and improve body composition in adults with Parkinson's disease who have undergone bilateral subthalamic nucleus deep brain stimulation (STN DBS). The study aims to see if adhering to this diet for three months after surgery can control weight gain and positively affect clinical factors like nutritional status, appetite, quality of life, and physical activity compared to usual diet. Parkinson's disease involves motor and non-motor symptoms, and DBS is a surgical treatment for patients with motor fluctuations despite medication. Post-surgery weight gain is a concern due to changes in food intake and activity levels, which this study seeks to address through dietary guidance. Participants will be randomly assigned to either an intervention group receiving Mediterranean diet recommendations or a control group continuing their usual eating habits. The Mediterranean diet group will receive nutritional training focused on consuming olive oil as the main fat, plenty of vegetables, fruits, fish, legumes, and nuts, while limiting bakery products, sugary snacks, and red meat. These guidelines will be reinforced during monthly follow-ups over three months after DBS device activation. The control group will maintain their routine diet without specific instructions. During the study, participants will undergo evaluations before surgery and at one, two, and three months after surgery. Assessments include appetite scales, Parkinson's disease questionnaires, dietary adherence scales, food consumption records, and physical activity questionnaires. Investigators will also measure body weight, body composition, waist and neck circumference, arm circumference, and handgrip strength. The primary outcomes focus on changes in body weight, height, and body mass index over three months, with additional measures related to nutritional status, motor symptoms, diet, quality of life, and appetite being monitored throughout the study.
CONDITIONS
Brief Title
Effect of Mediterranean Diet on Nutrition in Parkinson's Disease Patients With Bilateral Subthalamic Deep Brain Stimulation
Who Can Participate
Age: 45Years - 64Years
All Genders
Eligibility Criteria
You may qualify if you...
- Be between 45 and 64 years old
- Provide informed consent to participate
- Have undergone bilateral subthalamic nucleus deep brain stimulation surgery
- Continue antiparkinsonian treatment
- Have a Mini-Mental State Examination score of 24 or higher
You will not qualify if you...
- Have any psychiatric illness
- Have a Mini-Mental State Examination score below 24
- Have a disease requiring a special diet other than Parkinson's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 3 months
Participants follow either the Mediterranean diet or continue their usual diet for three months after activation of the deep brain stimulation device. Monthly nutritional training and follow-up interviews are provided to those in the Mediterranean diet group to support adherence.
Monthly visits for up to 3 months
Trial Site Locations
Total: 1 location
1
Ankara Etlik City Hospital
Ankara, Ankara, Turkey (Türkiye), 06290
Actively Recruiting
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Research Team
N
Nursena ERSOY SÖKE, MsC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Modulation of nutritional state in Parkinsonian patients with bilateral subthalamic nucleus stimulation.
Joana Guimarães, Eduarda Matos, Maria José Rosas...
https://pubmed.ncbi.nlm.nih.gov/19633906