Ketogenic Diets for Symptoms of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Unified Parkinson's Disease rating Scale, part III (motor)
研究概览
简要总结
Parkinson's disease is a progressive condition that harms nerve cells of the brain (neurodegeneration). Current treatments for Parkinson's disease (including levodopa and deep brain stimulation) improve certain symptoms but are not thought to improve the underlying neurodegenerative disease process (they are not a "cure"). The cause of Parkinson's disease is unknown. However, some evidence suggests that tiny structures in the investigators cells called "mitochondria" might be involved. Mitochondria are the powerhouses that produce fuel for the investigators cells. Failure of these 'powerhouses' to supply the energy needs of certain nerve cells might lead to Parkinson's disease. Preliminary evidence suggests that a food called 'ketones' might be able to enhance the function of mitochondria and improve Parkinson's disease symptoms and possibly even the neurodegenerative process. In this study, the investigators would like to investigate this possibility by giving patients with Parkinson's disease dietary supplements of 'ketone esters' in a drink. The investigators will then assess if this improves symptoms of Parkinson's disease.
The study design is a prospective, double blinded, randomised, controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 42 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Primary Parkinson's disease fulfilling UK Brain Bank criteria
- •Age of onset of Parkinson's disease symptoms > 40 years old
- •Duration of symptoms over 2 years
排除标准
- •Active psychosis
- •Deep brain stimulation or apomorphine infusion
- •Severe motor fluctuations
- •Significant metabolic or uncontrolled medical cormorbidity
研究组 & 干预措施
Ketone ester drink Vs placebo drink
Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both)
干预措施: Ketone ester drink (Dietary Supplement)
Ketone ester drink Vs placebo drink
Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both)
干预措施: Placebo (carbohydrate containing) drink (Dietary Supplement)
结局指标
主要结局
Unified Parkinson's Disease rating Scale, part III (motor)
时间窗: 5 days
Difference between ketone versus placebo scores
次要结局
- Computerised reaction time and cogntive tests(5 days)
- Unified Parkinson's disease rating scale, parts I, II, IV(5 days)
- Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)(5 days)
- Timed motor tasks as per CAPSIT(5 days)