Effect of Mediterranean Diet on Nutrition in Parkinson's Disease Patients With Bilateral Subthalamic Deep Brain Stimulation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Mediterranean diet.
- Кому может быть актуально
- Состояния в реестре: Parkinson Disease, Deep Brain Stimulation, Deep Brain Stimulation Surgery. Базовые параметры: 45 лет — 64 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Investigation of the Effect of the Mediterranean Diet on Nutritional Status in Parkinson's Patients Undergoing Bilateral Subthalamic Nucleus Deep Brain Stimulation
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Mediterranean diet
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 v
Первичные конечные точки
- Body weight [Срок оценки: From enrollment to the end of treatment at 3 months]
- Height [Срок оценки: From enrollment to the end of treatment at 3 months]
- Body Mass Index [Срок оценки: From enrollment to the end of treatment at 3 months]
Вторичные конечные точки (9)
- Triceps skinfold thickness [Срок оценки: From enrollment to the end of treatment at 3 months]
- Upper mid-arm circumference [Срок оценки: From enrollment to the end of treatment at 3 months]
- Upper mid-arm muscle circumference [Срок оценки: From enrollment to the end of treatment at 3 months]
- Upper mid-arm muscle area [Срок оценки: From enrollment to the end of treatment at 3 months]
- Motor symptoms related to nutrition [Срок оценки: From enrollment to the end of treatment at 3 months]
- Dietary Intake [Срок оценки: From enrollment to the end of treatment at 3 months]
- Life Quality [Срок оценки: From enrollment to the end of treatment at 3 months]
- Appetite Status [Срок оценки: From enrollment to the end of treatment at 3 months]
- Mediterranean Diet Adherence [Срок оценки: From enrollment to the end of treatment at 3 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Turkey (Türkiye) · 1 центр
- Ankara Etlik City Hospital — Ankara
Публикации
- 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
- 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
Идентификаторы
NCT: NCT07187739 · AEŞH-BADEK-2024-652