A Study to Determine Whether the Daily Consumption of Flavonoid-rich Pure Cocoa Can Reduce Fatigue in People With Parkinson's (PD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Fatigue Numerical Scale (FNS)
研究概览
简要总结
This study determines to evaluate the effectiveness of the daily consumption of flavonoid-rich cocoa in the treatment of fatigue in Parkinson's patients. The participants were divided equally between the flavonoid-rich cocoa (device) and control cocoa groups. The participant will engage in a six day trial, with measures taken at Day 1 and Day 6.
详细描述
Many pwPD have expressed their interest in dietary therapies to manage their symptoms; however scientific evidence for these therapies is lacking. Flavonoids, plant compounds found in certain foods, may have the ability to improve fatigue. However, to date, no well-designed intervention studies assessing the role of flavonoid consumption for fatigue management in pwPD have been performed.
The aim of this project is to undertake a feasibility preliminary study to determine whether flavonoid-rich cocoa has the potential to improve fatigue in pwPD in order to inform a follow on trial. Participants will be recruited from the European Parkinson Therapy Centre (EPTC) and will be those about to enrol onto the 6 day program. They will be required to consume a cocoa drink each morning for 6 days. They will have measures taken including fatigue measures using visual rating scales, walking tests and several questionnaires will be administered during this time.
Aims:
The hypothesis is that the consumption of a flavonoid-rich pure cocoa beverage will reduce fatigue in pwPD. The aim of this study is to determine the feasibility of a trial to evaluate this proposal.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blind randomized controlled feasibility trial with assessors and participant blinded to intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low flavonoid cocoa
A control cocoa beverage low inn flavonoids
干预措施: Cocoa (Dietary Supplement)
Flavonoid rich cocoa
Dark cocoa beverage rich in flavonoids
干预措施: Cocoa (Dietary Supplement)
结局指标
主要结局
Fatigue Numerical Scale (FNS)
时间窗: Change from Baseline to Day 6
The FFS measures the fatigue of an individual at set times throughout the day
次要结局
- 6-Minute Walking Test(Measurements taken at baseline and Day 6)
- Adult Memory and Information Processing Battery (AMIPB)(Measurements taken at baseline and Day 6)
- Final Evaluation Interview(Taken at day 6)
- Dietary Recall(Measurements taken at baseline and Day 6)
- Accelerometer(Measurements continuously taken from baseline to Day 6)
研究者
Shelly Coe
Principal investigator
Oxford Brookes University