Clinical Drug Experience Knowledgebase

A Study to Determine Whether the Daily Consumption of Flavonoid-rich Pure Cocoa Can Reduce Fatigue in People With Parkinson's (PD)

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:

This is a randomised double-blind placebo controlled feasibility study in which 20 (+ potentially 20 more if adherence is acceptable and recruitment is progressing as expected) pwPD will be recruited from the European Parkinson Therapy Centre (EPTC), Italy.

Intervention:

A 6 day nutrition intervention period, with a total of 2 assessments (baseline and day 6) where outcome measures will be assessed.

Population:

20 men and women with a diagnosis of PD and who are over 18 years of age. There will be 10 participants in each trial arm.

Outcome Measures:

In order to assess benefits, a range of outcomes will be obtained. Outcome measures include:

Levels of physical activity: wearable activity monitors (worn like a watch)

Dietary patterns: 2-24 hour dietary record

Fatigue levels: Fatigue Severity Scale (FSS) and during the intervention the numerical rating scale (NRS) 3 times daily

Fatigability: performance on 6 minute walk test (physical) and AMIPB cognitive test

Health descriptives: basic health questionnaire, Euroqol (EQ5DVAS), SF36 Health survey, Unified Parkinson's Disease Rating Scale non motor symptoms (UPDRSNMS), routinely administered to the centre by Trescore Hospital.

Duration and follow-up:

Participants will be consented by a trained researcher at the Centre and, if successfully pass the eligibility check will be enrolled into the study. Staff at the Centre will be trained on taking consent by researchers at OBU. Once a participant is enrolled, a baseline assessment (Assessment 1) will be conducted at day 1. Immediately following completion of Assessment 1, participants will be randomly allocated to either the high flavonoid intervention group or the control group, and intervention delivery will begin immediately after allocation. They will be reassessed at day 6. Those in the control group will follow the same procedure, the only difference being that they receive the low flavonoid drink. Alex Reed and the EPTC will inform participant GPs about their involvement in the study.