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

NCT07187739 | Recruiting

• 1 other identifier: AEŞH-BADEK-2024-652
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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). The main questions it aims to answer are: 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.

Conditions

Parkinson Disease; Deep Brain Stimulation; Deep Brain Stimulation Surgery

Keywords

Mediterranean Diet; Body Weight; Body Composition; Dietary Assesment; Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Body weight

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

  From enrollment to the end of treatment at 3 months

• 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.

  From enrollment to the end of treatment at 3 months

• Body Mass Index

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

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (9)

• Triceps skinfold thickness

  From enrollment to the end of treatment at 3 months

• Upper mid-arm circumference

  From enrollment to the end of treatment at 3 months

• Upper mid-arm muscle circumference

  From enrollment to the end of treatment at 3 months

• Upper mid-arm muscle area

  From enrollment to the end of treatment at 3 months

• Motor symptoms related to nutrition

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Control

NO INTERVENTION

Individuals in the control group will continue their routine nutrition.

Mediterranean Diet

EXPERIMENTAL

Individuals in the Mediterranean diet group will be given a Mediterranean diet.

Other: Mediterranean diet

Interventions

Mediterranean diet OTHER

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.

Mediterranean Diet

Eligibility Criteria

• Age: 45 Years - 64 Years
• Gender Eligibility Details: Participants will be randomized into 2 groups: intervention and control, based on age, gender, disease severity and body mass index.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, 06290, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 29274834 RESULT

• 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.

  PMID: 19633906 RESULT

MeSH Terms

Conditions

Parkinson Disease; Body Weight

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Nursena ERSOY SÖKE, MsC

CONTACT

(+90) 534 330 11 11; ersoynursena73@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: September 23, 2025
• Study Start: September 25, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)