Can a Flavonoid-rich Pure Cocoa Reduce Fatigue in People With Parkinson's (PD)

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288155
• Other study ID #: OxfordBU
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: September 2019
• Source: Oxford Brookes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Parkinson Disease

Intervention

Dietary Supplement:
• Cocoa
Participants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa.

Locations

Country	Name	City	State
Italy	European Parkinson Therapy Centre	Boario	Terme

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Brookes University	European Parkinson Therapy Centre

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Numerical Scale (FNS)	The FFS measures the fatigue of an individual at set times throughout the day	Change from Baseline to Day 6
Secondary	Adult Memory and Information Processing Battery (AMIPB)	The AIMPB test is taken after a fasted night, provided unseen to the participant. The participant must circle the second highest number out of five. There are ten lines of numbers. The test is timed.	Measurements taken at baseline and Day 6
Secondary	6-Minute Walking Test	The 6-minute walking test measures the participants' physical competency. It is taken after the AIMPB (on a fasted stomach). The participant must walk around a set course, of 13 metres, which is timed.	Measurements taken at baseline and Day 6
Secondary	Dietary Recall	The dietary recall is taken to ensure any extraneous factors, potentially affecting the severity of Parkinson's symptoms or fatigue. The dietary recall is taken on the first (Day 1) and last day (Day 6) of the trial. The participants are not notified of the dietary recall commencement dates, to ensure they do not change their natural eating habits.	Measurements taken at baseline and Day 6
Secondary	Accelerometer	The accelerometer measures the amount of activity expended by the participant during the duration of the trial (Day 1 to day 6). This is used to help distinguish variations between the FNS results, as well as fatigue related to physical exertion.	Measurements continuously taken from baseline to Day 6
Secondary	Final Evaluation Interview	This questionnaire is to discover views from the participant upon the cessation of the trial. Including whether the participant will continue to drink the cocoa.	Taken at day 6