A Clinical Study on the Effects of Ketoflex 12/3 Diet on Motor and Non-Motor Symptoms in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Motor Symptoms as Measured by the Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
This study aims to investigate the effects of the Ketoflex 12/3 diet on motor and non-motor symptoms in patients with Parkinson's disease. Participants will follow the Ketoflex 12/3 dietary regimen, and their cognitive function, motor symptoms, sleep patterns, gastrointestinal health, and overall well-being will be assessed through standardized clinical scales. The study will help determine whether a plant-based ketogenic diet combined with intermittent fasting can have a beneficial impact on Parkinson's disease progression.
详细描述
Parkinson's disease is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms. Emerging evidence suggests that dietary interventions, particularly ketogenic diets and intermittent fasting, may play a role in neuroprotection and symptom management. This study investigates the effects of the Ketoflex 12/3 diet, a plant-based ketogenic dietary approach combined with intermittent fasting, on Parkinson's disease progression. Clinical assessments will include Unified Parkinson's Disease Rating Scale (UPDRS), Mini-Mental State Examination (MMSE), depression and anxiety scales, sleep quality assessments, and gastrointestinal health evaluations. The study aims to provide new insights into the potential benefits of metabolic-based nutritional interventions in Parkinson's disease patients.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Parkinson's disease
- •Age between 40-85 years
- •Native Turkish speakers
- •Able to comply with the study protocol
排除标准
- •History of alcohol or substance dependence
- •Diagnosis of chronic renal failure
- •Presence of neuromuscular disorders
- •Having amalgam dental fillings and/or failure to remove them according to the SMART protocol
- •Severe vitamin deficiencies that have not been corrected prior to the study
结局指标
主要结局
Change in Motor Symptoms as Measured by the Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: Baseline and 6 months
The Unified Parkinson's Disease Rating Scale (UPDRS) is used to evaluate the severity of motor symptoms in Parkinson's disease. Scores range from 0 to 108 for the motor section, with higher scores indicating worse motor impairment.
次要结局
未报告次要终点
研究者
Prof. Lutfu Hanoglu, MD
Professor.MD.PhD
Istanbul Medipol University Hospital