Clinical trial NCT03288155: Can a Flavonoid-rich Pure Cocoa Reduce Fatigue in People With Parkinson's (PD)
Official title: A Study to Determine Whether the Daily Consumption of Flavonoid-rich Pure Cocoa Can Reduce Fatigue in People With Parkinson's (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Fatigue
Keywords: Parkinson's
Fatigue
Flavonoid
Cocoa
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: European Parkinson Therapy Centre
First posted: 2017-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

* 18 years + with a clinical diagnosis of Parkinson's disease
* Sufficient mental capacity to consent
* Score of 1-2 on Hoehn and Yahr scale

Exclusion Criteria

* Change in medication before the previous week of the trial and/ or an expected change during
* Known psychiatric disorder (clinically diagnosed)
* Contraindications tolerating the cocoa drink
* Other conditions that may be associated with fatigue, e.g. Anaemia
* Condition affecting the central nervous system other than Parkinson's disease (however migraine is allowed)
* Pregnant or lactating
* Objection to contacting their GP and neurologist

Primary outcomes:
measure: Fatigue Numerical Scale (FNS)
timeFrame: Change from Baseline to Day 6
Secondary outcomes:
measure: Adult Memory and Information Processing Battery (AMIPB)
timeFrame: Measurements taken at baseline and Day 6
measure: 6-Minute Walking Test
timeFrame: Measurements taken at baseline and Day 6
measure: Dietary Recall
timeFrame: Measurements taken at baseline and Day 6
measure: Accelerometer
timeFrame: Measurements continuously taken from baseline to Day 6
measure: Final Evaluation Interview
timeFrame: Taken at day 6
Other outcomes:
Locations:
city: Boario
country: Italy
facility: European Parkinson Therapy Centre
state: Terme
Study officials:
affiliation: Oxford Brookes Univeristy
name: Shelly A Coe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Parkinson Therapy Centre
name: Alex Reed
role: STUDY_DIRECTOR
References:
citation: Coe S, Andreoli D, George M, Collett J, Reed A, Cossington J, Izadi H, Dixon A, Mansoubi M, Dawes H. A feasibility study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue and fatigability in people with Parkinson's (pwP). Clin Nutr ESPEN. 2022 Apr;48:68-73. doi: 10.1016/j.clnesp.2022.01.023. Epub 2022 Jan 31.