Effect of Mediterranean Diet on Nutrition in Parkinson's Disease Patients With Bilateral Subthalamic Deep Brain Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-64
SponsorAnkara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being between 45-64 years of age
Signing informed consent
Undergoing STN DBS surgery
Continuing antiparkinsonian therapy
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Mediterranean diet
Other interventionAll 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Mediterranean DietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Body weight
The body weights of the individuals will be measured with a body analyzer sensitive to 0.1 kilograms for all participants.
Time frame
From enrollment to the end of treatment at 3 months2
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.
Time frame
From enrollment to the end of treatment at 3 months3
Body Mass Index
Body Mass Index will be reported in kg/m² by dividing the body weight by the square of the height.
Time frame
From enrollment to the end of treatment at 3 monthsSecondary outcomes
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.
Time frame
From enrollment to the end of treatment at 3 months2
Upper mid-arm circumference
The upper mid-arm circumference will be measured in cm with a non-stretchable tape measure.
Time frame
From enrollment to the end of treatment at 3 months3
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.
Time frame
From enrollment to the end of treatment at 3 months4
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.
Time frame
From enrollment to the end of treatment at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov