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临床试验/NCT07187739
NCT07187739招募中不适用

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

Ankara University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Body weight

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Mediterranean diet (Other)

结局指标

主要结局

Body weight

时间窗: From enrollment to the end of treatment at 3 months

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

Height

时间窗: From enrollment to the end of treatment at 3 months

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.

Body Mass Index

时间窗: From enrollment to the end of treatment at 3 months

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

次要结局

  • 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)
  • Dietary Intake(From enrollment to the end of treatment at 3 months)
  • Life Quality(From enrollment to the end of treatment at 3 months)
  • Appetite Status(From enrollment to the end of treatment at 3 months)
  • Mediterranean Diet Adherence(From enrollment to the end of treatment at 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nursena ERSOY SÖKE

Principal Investigator

Ankara University

研究点 (1)

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