Parkinson DiseaseNCT03288155
Can a Flavonoid-rich Pure Cocoa Reduce Fatigue in People With Parkinson's (PD)
A study testing Cocoa in people with Parkinson Disease and Fatigue, run by Oxford Brookes University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Fatigue
- What is being tested?
- Cocoa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years + with a clinical diagnosis of Parkinson's disease
- Sufficient mental capacity to consent
- Score of 1-2 on Hoehn and Yahr scale
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Fatigue
- Being tested
- Cocoa
- Keywords
- Parkinson's, Fatigue, Flavonoid, Cocoa
- Medical subject headings
- Parkinson Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocoaDietary supplement
Participants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa.
| Study group | Role | What they receive |
|---|---|---|
| Flavonoid rich cocoa | Experimental | Dark cocoa beverage rich in flavonoids Receives: Dietary Supplement: Cocoa |
| Low flavonoid cocoa | Placebo comparator | A control cocoa beverage low inn flavonoids Receives: Dietary Supplement: Cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Numerical Scale (FNS)
The FFS measures the fatigue of an individual at set times throughout the day
Measured: Change from Baseline to Day 6
Secondary outcomes (5)
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.
Measured: Measurements taken at baseline and Day 6
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.
Measured: Measurements taken at baseline and Day 6
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.
Measured: Measurements taken at baseline and Day 6
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.
Measured: Measurements continuously taken from baseline to Day 6
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.
Measured: Taken at day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Jul 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- European Parkinson Therapy Centre
- Responsible party
- Principal investigator, Shelly Coe, Oxford Brookes University
- Investigators
- Shelly A Coe, PhD, Principal investigator, Oxford Brookes UniveristyAlex Reed, Study director, European Parkinson Therapy Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288155
- Sponsor's protocol ID
- OxfordBU
- Status last verified
- Sep 2019
- First submitted
- 15 Sep 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data would be anonymised and potentially available for public use
Publications
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.
PubMed 35331536
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine Whether the Daily Consumption of Flavonoid-rich Pure Cocoa Can Reduce Fatigue in People With Parkinson's (PD)
- ClinicalTrials.gov ID
- NCT03288155
- Acronym / sponsor ID
- OxfordBU
- Conditions
- Parkinson Disease, Fatigue
- Keywords
- Parkinson's, Fatigue, Flavonoid, Cocoa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- European Parkinson Therapy Centre
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavonoid rich cocoa | Experimental | Dietary Supplement: CocoaDark cocoa beverage rich in flavonoids |
| Low flavonoid cocoa | Placebo comparator | Dietary Supplement: CocoaA control cocoa beverage low inn flavonoids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years + with a clinical diagnosis of Parkinson's disease
- Sufficient mental capacity to consent
- Score of 1-2 on Hoehn and Yahr scale
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CocoaParticipants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa. | Dietary supplement | Flavonoid rich cocoa, Low flavonoid cocoa |
Primary outcome
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
5 secondary outcomes
Adult Memory and Information Processing Battery (AMIPB)
Time frame: Measurements taken at baseline and Day 6
6-Minute Walking Test
Time frame: Measurements taken at baseline and Day 6
Dietary Recall
Time frame: Measurements taken at baseline and Day 6
Accelerometer
Time frame: Measurements continuously taken from baseline to Day 6
Final Evaluation Interview
Time frame: Taken at day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 35331536Coe 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.
- Individual participant dataSharing planned: Undecided. Data would be anonymised and potentially available for public use
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelly A Coe, PhD principal investigator
Oxford Brookes Univeristy
Alex Reed study director
European Parkinson Therapy Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa in people with Parkinson Disease and Fatigue, run by Oxford Brookes University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Numerical Scale (FNS) (time frame: Change from Baseline to Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.