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Parkinson DiseaseNCT07187739

Effect of Mediterranean Diet on Nutrition in Parkinson's Disease Patients With Bilateral Subthalamic Deep Brain Stimulation

A study testing Mediterranean diet in people with Parkinson Disease and Deep Brain Stimulation, run by Ankara University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate whether Mediterranean diet can help manage body weight and improve body composition in adult Parkinson's disease patients who have undergone bilateral subthalamic nucleus deep brain stimulation (STN DBS). Read more about this study

Who is it for?
Ages 45 to 64 years
What is being tested?
Mediterranean diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Sep 2025to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Being between 45-64 years of age
  • Signing informed consent
  • Undergoing STN DBS surgery
  • Continuing antiparkinsonian therapy
  • Those with a Mini Mental Test result of ≥24 points

Who cannot join

  • Having any psychiatric illness
  • Those with a Mini Mental Test result of <24 points
  • Those with a disease requiring a special diet other than Parkinson's Disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nursena ERSOY SÖKE, MsC contact

(+90) 534 330 11 11

ersoynursena73@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara Etlik City Hospital

    Ankara, Ankara, 06290

    Nursena Ersoy Söke, +0905343301111, nsersoy@ankara.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect of the Mediterranean Diet on Nutritional Status in Parkinson's Patients Undergoing Bilateral Subthalamic Nucleus Deep Brain Stimulation

The goal of this clinical trial is to evaluate whether Mediterranean diet can help manage body weight and improve body composition in adult Parkinson's disease patients who have undergone bilateral subthalamic nucleus deep brain stimulation (STN DBS).

The main questions it aims to answer are:

Read more

Does adherence to the Mediterranean diet for three months post-surgery help control body weight gain in STN DBS patients?

Does the Mediterranean diet positively affect body composition and other clinical parameters such as nutritional status, appetite, quality of life, and physical activity?

Researchers will compare an intervention group following the Mediterranean diet with a control group continuing their usual diet to see if dietary guidance leads to improvements in weight management, body composition, and other nutritional status parameters.

Participants will:

Be randomized into intervention and control groups.

Receive Mediterranean dietary recommendations (intervention group) or continue usual diet (control group).

Undergo evaluations at baseline (pre-operative), and at the 1st, 2nd, and 3rd months post-operatively using the following tools:

Visual Appetite Scale

Hoehn and Yahr Questionnaire

Parkinson's Disease Quality of Life Questionnaire-8

Movement Disorder Society-Unified Parkinson's Disease Rating Scale - Part 2

Mediterranean Diet Adherence Scale

Food Consumption Record

Have their anthropometric measurements and body composition (e.g., weight, waist and neck circumference, upper arm circumference, handgrip strength) assessed.

Read the detailed description

Parkinson's disease is a neurodegenerative disease characterized by the loss of dopaminergic neurons in the substantia nigra region. Although the prevalence of Parkinson's disease varies according to gender and geographical region, the prevalence increases with age. Parkinson's Disease is characterized by three motor symptoms: tremor, bradykinesia and rigidity. Aside from motor symptoms, non-motor symptoms are also present. The majority of non-motor symptoms consist of gastrointestinal symptoms such as dysphagia, gastroparesis and constipation. The most effective pharmacological drug for treating motor symptoms in Parkinson's patients is levodopa (3,4-dihydroxyphenylalanine). Deep brain stimulation (DBS: Deep Brain Stimulation) may be a treatment option in patients who have motor fluctuation, dyskinesia or tremor symptoms despite optimal drug therapy. Deep brain stimulation is a minimally invasive, targeted neurosurgical intervention that involves placing electrodes and a pacemaker that electrically stimulates these electrodes in structures deep in the brain. Over the past 25 years, deep brain stimulation has been used extensively to target various brain regions. The most preferred method is Subthalamic Nucleus DBS. The suitability of this treatment for patients is determined by a multidisciplinary team based on the presence of various indications. In these patients, body weight gain may be observed after surgery due to increased food intake, decreased motor symptoms, and decreased energy expenditure due to physical activity. Body weight is associated with increasing levodopa dosage, dyskinesia, and risk of metabolic syndrome. To prevent this important side effect of DBS, the European Society of Enteral and Parenteral Nutrition emphasizes nutritional therapy in patients to control post-operative body weight gain and prevent the onset of metabolic disorders. The primary aim of this study was to examine the effect of Mediterranean dietary recommendations on body weight and body composition during three months post-operatively in adult patients undergoing STN DBS. Inclusion criteria for the study are as follows: being between 45 and 64 years of age, volunteering to participate, having undergone bilateral subthalamic nucleus deep brain stimulation (STN DBS) surgery, continuing antiparkinsonian treatment, and having a Mini-Mental State Examination (MMSE) score of 24 or higher. Exclusion criteria include having any psychiatric disorder, having a Mini-Mental State Examination (MMSE) score below 24, and having a disease other than Parkinson's disease that requires a special diet. Participants who meet the inclusion criteria will be randomized into two groups: intervention and control groups. Participants in the control group will be instructed to continue their current eating habits. Participants' appetite will be assessed by the investigators using the "Visual Appetite Scale", disease stage using the "Hoehn and Yahr Questionnaire", quality of life using the "Parkinson Disease Quality of Life Questionnaire-8", motor symptoms related to feeding (chewing and swallowing, eating) using the "Movement Disorder Society Unified Parkinson's Disease Rating Scale - Part 2", adherence to the Mediterranean diet using the "Mediterranean Diet Adherence Scale", diet assessment using the "Food Consumption Record" and physical activity status using the "International Physical Activity Questionnaire-Short Form" by the investigators. In order to determine the daily energy and nutrient consumption status of participants, a 24-hour dietary recall will be taken in the pre-operative interview, and a total of three days of food consumption records will be taken in the post-operative 1st, 2nd and 3rd interviews, one day of which will be 24-hour recall and two days of which will be food recording method. Visual Appetite Scale, Hoehn and Yahr Questionnaire, Parkinson's Disease Quality of Life Questionnaire-8, Movement Disorder Association Unified Parkinson's Disease Rating Scale - Part 2, and Mediterranean Diet Adherence Scale will be applied by the investigators to all participants at preoperative, post-operative 1st, 2nd and 3rd month. In addition, participants' anthropometric measurements (body weight, waist circumference, neck circumference, upper mid-arm circumference, handgrip strength) and body composition will be evaluated by the investigators. All data obtained during the research process will be evaluated using appropriate statistical analysis.

Being tested
Mediterranean diet
Keywords
Mediterranean Diet, Body Weight, Body Composition, Dietary Assesment, Parkinson Disease
Medical subject headings
Parkinson Disease, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mediterranean dietOther

    All individuals in the intervention group will be instructed to adhere to Mediterranean diet recommendations for a period of three months following the activation of the deep brain stimulation device. Nutritional training sessions focusing on the Mediterranean diet will be provided and reinforced during monthly follow-up interviews. In line with these recommendations, olive oil will be promoted as the primary dietary fat. Participants will be encouraged to consume a minimum of 300-400 grams of vegetables daily and 450 grams of fresh fruit or alternatively, 300 grams of fresh fruit and 30 grams of dried fruit. The consumption of bakery products, sugary snacks, and carbonated beverages will be discouraged. White meat will be favored over red meat in meal planning. Participants will also be advised to include 450 grams of fish, 30 grams of oilseeds, and 180 grams of legumes in their weekly diets. There is no routine Mediterranean diet recommendation after STN DBS.

Study groups in NCT07187739
Study groupRoleWhat they receive
ControlNo interventionIndividuals in the control group will continue their routine nutrition.
Mediterranean DietExperimentalIndividuals in the Mediterranean diet group will be given a Mediterranean diet.
Receives: Other: Mediterranean diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    The body weights of the individuals will be measured with a body analyzer sensitive to 0.1 kilograms for all participants.

    Measured: From enrollment to the end of treatment at 3 months

  2. Height

    The height of the participants will be measured in cm with a portable stadiometer without shoes, with the head in an upright position and in the Frankfort plane.

    Measured: From enrollment to the end of treatment at 3 months

  3. Body Mass Index

    Body Mass Index will be reported in kg/m² by dividing the body weight by the square of the height.

    Measured: From enrollment to the end of treatment at 3 months

Secondary outcomes (9)
  1. Triceps skinfold thickness

    The triceps skinfold thickness will be measured using a caliper in mm and will be used to evaluate the adipose tissue.

    Measured: From enrollment to the end of treatment at 3 months

  2. Upper mid-arm circumference

    The upper mid-arm circumference will be measured in cm with a non-stretchable tape measure.

    Measured: From enrollment to the end of treatment at 3 months

  3. Upper mid-arm muscle circumference

    Upper mid-arm muscle circumference will be calculated using the upper mid-arm circumference and triceps skinfold thickness to evaluate lean body mass. It is expressed in cm.

    Measured: From enrollment to the end of treatment at 3 months

  4. Upper mid-arm muscle area

    The upper mid-arm muscle area will be calculated using the upper mid-arm circumference and triceps skinfold thickness to evaluate lean body mass. It is expressed in cm².

    Measured: From enrollment to the end of treatment at 3 months

  5. Motor symptoms related to nutrition

    Motor symptoms related to nutrition (chewing and swallowing, eating) will be assessed by the "Movement Disorder Association Unified Parkinson's Disease Assessment Scale-Part 2". The 2.2 chewing and swallowing questions and the 2.4 eating questions in Section 2 will be evaluated. These questions are on a 5-point Likert type, from 0 (normal) to 1 (severe). Higher scores indicate higher swallowing, chewing, and swallowing symptoms.

    Measured: From enrollment to the end of treatment at 3 months

  6. Dietary Intake

    The dietary intake of the individuals will be assessed by the "Food Consumption Record" preoperatively and at the 1st, 2nd, and 3rd months postoperatively for the individuals in both groups. In order to determine the daily energy and nutrient consumption status of the individuals, a 24-hour retrospective daily food consumption record will be taken in the pre-operative interview, and a total of three days of food consumption records will be taken in the post-operative 1st, 2nd, and 3rd interviews, one day of which will be 24-hour retrospective and the other two days of which will be the food recording method. If there are records that are considered to be incomplete or incorrect, the individual will be asked again and corrected. The energy and nutrients of the daily consumed foods will be calculated using the Nutrition Information System (BEBIS) program.

    Measured: From enrollment to the end of treatment at 3 months

  7. Life Quality

    The "Parkinson's Disease Quality of Life Questionnaire-8" will be used for quality of life.The Parkinson's Disease Questionnaire-8 is a 5-point Likert scale with each of the 8 items ranging from 0 (never) to 4 (always). The total score is calculated by summing all items and the scores are converted to values between 0 and 100. Higher scores indicate worse quality of life.

    Measured: From enrollment to the end of treatment at 3 months

  8. Appetite Status

    The appetite status will be assessed using a 100 mm visual analogue scale. The visual appetite scale is marked on the 100 mm line as "My appetite is very poor," "My appetite is poor", "My appetite is moderate," "My appetite is good," and "My appetite is very good". Participants will be asked to place a vertical mark on the line that best reflects their appetite. Each score will be determined by measuring the distance from the left side of the line to the mark.

    Measured: From enrollment to the end of treatment at 3 months

  9. Mediterranean Diet Adherence

    The compliance with the Mediterranean diet will be assessed by the "Mediterranean Diet Adherence Scale". The Mediterranean Diet Adherence Scale is a 14-question questionnaire. The Turkish validity and reliability study of this scale was conducted. This scale questions the basic oil type used in individuals' meals, olive oil consumption, vegetable and fruit consumption, red meat consumption, butter and margarine consumption, daily amounts of sugary or sweetened beverage consumption, and weekly amounts of wine, legumes, fish/seafood, processed desserts or pastries, hazelnuts, and olive oil with sauce. In addition, the scale includes whether the individual prefers white meat over red meat in their diet. A total score is calculated by giving 0 or 1 points to each question asked according to the amount of consumption. A total score of 7 and above indicates that the individual has an acceptable level of compliance with the Mediterranean diet.

    Measured: From enrollment to the end of treatment at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study start25 Sep 2025
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07187739
Sponsor's protocol ID
AEŞH-BADEK-2024-652
Status last verified
Oct 2025
First submitted
19 May 2025
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burgos R, Breton I, Cereda E, Desport JC, Dziewas R, Genton L, Gomes F, Jesus P, Leischker A, Muscaritoli M, Poulia KA, Preiser JC, Van der Marck M, Wirth R, Singer P, Bischoff SC. ESPEN guideline clinical nutrition in neurology. Clin Nutr. 2018 Feb;37(1):354-396. doi: 10.1016/j.clnu.2017.09.003. Epub 2017 Sep 22.

    PubMed 29274834
  • Guimaraes J, Matos E, Rosas MJ, Vieira-Coelho A, Borges N, Correia F, Vaz R, Garrett C. Modulation of nutritional state in Parkinsonian patients with bilateral subthalamic nucleus stimulation. J Neurol. 2009 Dec;256(12):2072-8. doi: 10.1007/s00415-009-5252-x.

    PubMed 19633906

Questions about this trial

What is this clinical trial studying?

A study testing Mediterranean diet in people with Parkinson Disease and Deep Brain Stimulation, run by Ankara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nursena ERSOY SÖKE, MsC ((+90) 534 330 11 11, ersoynursena73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: From enrollment to the end of treatment at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07187739, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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