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

September 4, 2019 updated by: Shelly Coe, Oxford Brookes University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Terme
      • Boario, Terme, Italy, 25041
        • European Parkinson Therapy Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flavonoid rich cocoa
Dark cocoa beverage rich in flavonoids
Dietary supplement: Cocoa
Participants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa.
Placebo Comparator: Low flavonoid cocoa
A control cocoa beverage low inn flavonoids
Dietary supplement: Cocoa
Participants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Numerical Scale (FNS)
Time Frame: Change from Baseline to Day 6
The FFS measures the fatigue of an individual at set times throughout the day
Change from Baseline to Day 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adult Memory and Information Processing Battery (AMIPB)
Time Frame: Measurements taken at baseline and Day 6
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
6-Minute Walking Test
Time Frame: Measurements taken at baseline and Day 6
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
Dietary Recall
Time Frame: Measurements taken at baseline and Day 6
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
Accelerometer
Time Frame: Measurements continuously taken from baseline to Day 6
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
Final Evaluation Interview
Time Frame: Taken at day 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford Brookes University

Collaborators

European Parkinson Therapy Centre

Investigators

  • Principal Investigator: Shelly A Coe, PhD, Oxford Brookes Univeristy
  • Study Director: Alex Reed, European Parkinson Therapy Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OxfordBU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data would be anonymised and potentially available for public use

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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