<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03288155</url>
  </required_header>
  <id_info>
    <org_study_id>OxfordBU</org_study_id>
    <nct_id>NCT03288155</nct_id>
  </id_info>
  <brief_title>Can a Flavonoid-rich Pure Cocoa Reduce Fatigue in People With Parkinson's (PD)</brief_title>
  <official_title>A Study to Determine Whether the Daily Consumption of Flavonoid-rich Pure Cocoa Can Reduce Fatigue in People With Parkinson's (PD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford Brookes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Parkinson Therapy Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oxford Brookes University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study determines to evaluate the effectiveness of the daily consumption of&#xD;
      flavonoid-rich cocoa in the treatment of fatigue in Parkinson's patients. The participants&#xD;
      were divided equally between the flavonoid-rich cocoa (device) and control cocoa groups. The&#xD;
      participant will engage in a six day trial, with measures taken at Day 1 and Day 6.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many pwPD have expressed their interest in dietary therapies to manage their symptoms;&#xD;
      however scientific evidence for these therapies is lacking. Flavonoids, plant compounds found&#xD;
      in certain foods, may have the ability to improve fatigue. However, to date, no well-designed&#xD;
      intervention studies assessing the role of flavonoid consumption for fatigue management in&#xD;
      pwPD have been performed.&#xD;
&#xD;
      The aim of this project is to undertake a feasibility preliminary study to determine whether&#xD;
      flavonoid-rich cocoa has the potential to improve fatigue in pwPD in order to inform a follow&#xD;
      on trial. Participants will be recruited from the European Parkinson Therapy Centre (EPTC)&#xD;
      and will be those about to enrol onto the 6 day program. They will be required to consume a&#xD;
      cocoa drink each morning for 6 days. They will have measures taken including fatigue measures&#xD;
      using visual rating scales, walking tests and several questionnaires will be administered&#xD;
      during this time.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      The hypothesis is that the consumption of a flavonoid-rich pure cocoa beverage will reduce&#xD;
      fatigue in pwPD. The aim of this study is to determine the feasibility of a trial to evaluate&#xD;
      this proposal.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This is a randomised double-blind placebo controlled feasibility study in which 20 (+&#xD;
      potentially 20 more if adherence is acceptable and recruitment is progressing as expected)&#xD;
      pwPD will be recruited from the European Parkinson Therapy Centre (EPTC), Italy.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      A 6 day nutrition intervention period, with a total of 2 assessments (baseline and day 6)&#xD;
      where outcome measures will be assessed.&#xD;
&#xD;
      Population:&#xD;
&#xD;
      20 men and women with a diagnosis of PD and who are over 18 years of age. There will be 10&#xD;
      participants in each trial arm.&#xD;
&#xD;
      Outcome Measures:&#xD;
&#xD;
      In order to assess benefits, a range of outcomes will be obtained. Outcome measures include:&#xD;
&#xD;
      Levels of physical activity: wearable activity monitors (worn like a watch)&#xD;
&#xD;
      Dietary patterns: 2-24 hour dietary record&#xD;
&#xD;
      Fatigue levels: Fatigue Severity Scale (FSS) and during the intervention the numerical rating&#xD;
      scale (NRS) 3 times daily&#xD;
&#xD;
      Fatigability: performance on 6 minute walk test (physical) and AMIPB cognitive test&#xD;
&#xD;
      Health descriptives: basic health questionnaire, Euroqol (EQ5DVAS), SF36 Health survey,&#xD;
      Unified Parkinson's Disease Rating Scale non motor symptoms (UPDRSNMS), routinely&#xD;
      administered to the centre by Trescore Hospital.&#xD;
&#xD;
      Duration and follow-up:&#xD;
&#xD;
      Participants will be consented by a trained researcher at the Centre and, if successfully&#xD;
      pass the eligibility check will be enrolled into the study. Staff at the Centre will be&#xD;
      trained on taking consent by researchers at OBU. Once a participant is enrolled, a baseline&#xD;
      assessment (Assessment 1) will be conducted at day 1. Immediately following completion of&#xD;
      Assessment 1, participants will be randomly allocated to either the high flavonoid&#xD;
      intervention group or the control group, and intervention delivery will begin immediately&#xD;
      after allocation. They will be reassessed at day 6. Those in the control group will follow&#xD;
      the same procedure, the only difference being that they receive the low flavonoid drink. Alex&#xD;
      Reed and the EPTC will inform participant GPs about their involvement in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Double blind randomized controlled feasibility trial with assessors and participant blinded to intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue Numerical Scale (FNS)</measure>
    <time_frame>Change from Baseline to Day 6</time_frame>
    <description>The FFS measures the fatigue of an individual at set times throughout the day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adult Memory and Information Processing Battery (AMIPB)</measure>
    <time_frame>Measurements taken at baseline and Day 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-Minute Walking Test</measure>
    <time_frame>Measurements taken at baseline and Day 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Recall</measure>
    <time_frame>Measurements taken at baseline and Day 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accelerometer</measure>
    <time_frame>Measurements continuously taken from baseline to Day 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final Evaluation Interview</measure>
    <time_frame>Taken at day 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Flavonoid rich cocoa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dark cocoa beverage rich in flavonoids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low flavonoid cocoa</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A control cocoa beverage low inn flavonoids</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cocoa</intervention_name>
    <description>Participants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa.</description>
    <arm_group_label>Flavonoid rich cocoa</arm_group_label>
    <arm_group_label>Low flavonoid cocoa</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  18 years + with a clinical diagnosis of Parkinson's disease&#xD;
&#xD;
          -  Sufficient mental capacity to consent&#xD;
&#xD;
          -  Score of 1-2 on Hoehn and Yahr scale&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Change in medication before the previous week of the trial and/ or an expected change&#xD;
             during&#xD;
&#xD;
          -  Known psychiatric disorder (clinically diagnosed)&#xD;
&#xD;
          -  Contraindications tolerating the cocoa drink&#xD;
&#xD;
          -  Other conditions that may be associated with fatigue, e.g. Anaemia&#xD;
&#xD;
          -  Condition affecting the central nervous system other than Parkinson's disease (however&#xD;
             migraine is allowed)&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Objection to contacting their GP and neurologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shelly A Coe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oxford Brookes Univeristy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alex Reed</last_name>
    <role>Study Director</role>
    <affiliation>European Parkinson Therapy Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>European Parkinson Therapy Centre</name>
      <address>
        <city>Boario</city>
        <state>Terme</state>
        <zip>25041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oxford Brookes University</investigator_affiliation>
    <investigator_full_name>Shelly Coe</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Parkinson's</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Flavonoid</keyword>
  <keyword>Cocoa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data would be anonymised and potentially available for public use</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03288155
org study id: OxfordBU
nct id: NCT03288155
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Double blind randomized controlled feasibility trial with assessors and participant blinded to intervention
measure: Fatigue Numerical Scale (FNS)
time frame: Change from Baseline to Day 6
description: The FFS measures the fatigue of an individual at set times throughout the day
measure: Adult Memory and Information Processing Battery (AMIPB)
time frame: Measurements taken at baseline and Day 6
description: 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.
measure: 6-Minute Walking Test
time frame: Measurements taken at baseline and Day 6
description: 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.
measure: Dietary Recall
time frame: Measurements taken at baseline and Day 6
description: 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.
measure: Accelerometer
time frame: Measurements continuously taken from baseline to Day 6
description: 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.
measure: Final Evaluation Interview
time frame: Taken at day 6
description: 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.
arm group label: Flavonoid rich cocoa
arm group type: Experimental
description: Dark cocoa beverage rich in flavonoids
arm group label: Low flavonoid cocoa
arm group type: Placebo Comparator
description: A control cocoa beverage low inn flavonoids
intervention type: Dietary Supplement
intervention name: Cocoa
description: Participants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa.
arm group label: Flavonoid rich cocoa
arm group label: Low flavonoid cocoa
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shelly A Coe, PhD
role: Principal Investigator
affiliation: Oxford Brookes Univeristy
last name: Alex Reed
role: Study Director
affiliation: European Parkinson Therapy Centre
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Oxford Brookes University
investigator full name: Shelly Coe
investigator title: Principal investigator
mesh term: Parkinson Disease
mesh term: Fatigue
sharing ipd: Undecided
ipd description: Data would be anonymised and potentially available for public use