Evaluation of Plasma Concentrations of Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in plasma concentrations of pharmacologically active constituents of chocolate after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
研究概览
简要总结
This study evaluates plasma concentrations of pharmacologically active constituents of chocolate and their effects on motor and non-motor symptoms of Parkinson's disease. Following one week of abstinence from cocoa-containing products, patients with Parkinson's disease will be randomized to receive either dark or white chocolate. After one week of chocolate consumption, patients will then cross over to white or dark chocolate, respectively, and take the corresponding chocolate product for another week. Blood samples will be taken at baseline, week 1 and week 2 to examine plasma concentrations of pharmacologically active constituents of chocolate at all three timepoints. Moreover, patients will be clinically examined for motor and non-motor symptoms at all visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male individuals aged 40 years and above
- •Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- •Hoehn and Yahr stage I-III
- •Minimum score of 16 points in the motor part of the Unified Parkinson Disease Rating Scale (UPDRS part III)
- •Stable antiparkinsonian medication for at least 4 weeks prior to study inclusion
- •Ability to provide informed consent
排除标准
- •Clinical signs for a secondary or atypical Parkinsonian syndrome
- •Treatment with any investigational medical product within 30 days prior to study inclusion
- •Intake of chocolate or other cocoa-containing products within the last 7 days prior to study inclusion (patients can be re-screened after 7 days of abstinence from chocolate and other cocoa-containing products)
- •Known intolerance or allergies against chocolate or other cocoa-containing products
- •Diabetes mellitus and/or impaired glucose tolerance in the medical history
- •Alcohol or drug abuse in the medical history
- •Presence of levodopa-induced motor complications
- •Other neurological, psychiatric or miscellaneous conditions that would significantly impair study participation, medical assessments or the consenting process
结局指标
主要结局
Change in plasma concentrations of pharmacologically active constituents of chocolate after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
时间窗: 7 days
Change in the severity of motor and non-motor symptoms of PD after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
时间窗: 7 days
Changes in motor symptoms will be assessed with the UPDRS, changes in non-motor symptoms will be assessed with NMSS and NMSQuest.
次要结局
- Change in cognitive measures (MoCA, SCOPA-COG) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate(7 days)
- Change in depressive symptoms (BDI-II) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate(7 days)
- Change in the quality of life (PDQ-39) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate(7 days)