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Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease (Choc-PD)

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ClinicalTrials.gov Identifier: NCT02275884
Recruitment Status : Unknown
Verified October 2014 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : October 27, 2014
Last Update Posted : October 27, 2014
Sponsor:
Collaborator:
University of Wuerzburg
Information provided by (Responsible Party):
Technische Universität Dresden

Study Description
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Brief Summary:
This study evaluates plasma concentrations of pharmacologically active constituents of chocolate and their effects on motor and non-motor symptoms of Parkinson's disease. Following one week of abstinence from cocoa-containing products, patients with Parkinson's disease will be randomized to receive either dark or white chocolate. After one week of chocolate consumption, patients will then cross over to white or dark chocolate, respectively, and take the corresponding chocolate product for another week. Blood samples will be taken at baseline, week 1 and week 2 to examine plasma concentrations of pharmacologically active constituents of chocolate at all three timepoints. Moreover, patients will be clinically examined for motor and non-motor symptoms at all visits.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dietary Supplement: Dark chocolate (85% cocoa) Dietary Supplement: White chocolate (0% cocoa) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Evaluation of Plasma Concentrations of Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease
Study Start Date : June 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dark chocolate (85% cocoa)
Patients will initially receive 50 grams of dark chocolate (85% cocoa) b.i.d. for one week. Patients will then cross over to intake of 50 grams of white chocolate (0% cocoa) b.i.d. for another week.
 Dietary Supplement: Dark chocolate (85% cocoa)
Dietary Supplement: White chocolate (0% cocoa)
Sham Comparator: White chocolate (0% cocoa)
Patients will initially receive 50 grams of white chocolate (0% cocoa) b.i.d. for one week. Patients will then cross over to intake of 50 grams of dark chocolate (85% cocoa) b.i.d. for another week.
 Dietary Supplement: Dark chocolate (85% cocoa)
Dietary Supplement: White chocolate (0% cocoa)


Outcome Measures
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Primary Outcome Measures :
  1. Change in plasma concentrations of pharmacologically active constituents of chocolate after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate [ Time Frame: 7 days ]
  2. Change in the severity of motor and non-motor symptoms of PD after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate [ Time Frame: 7 days ]
    Changes in motor symptoms will be assessed with the UPDRS, changes in non-motor symptoms will be assessed with NMSS and NMSQuest.


Secondary Outcome Measures :
  1. Change in cognitive measures (MoCA, SCOPA-COG) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate [ Time Frame: 7 days ]
  2. Change in depressive symptoms (BDI-II) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate [ Time Frame: 7 days ]
  3. Change in the quality of life (PDQ-39) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male individuals aged 40 years and above
  • Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
  • Hoehn and Yahr stage I-III
  • Minimum score of 16 points in the motor part of the Unified Parkinson Disease Rating Scale (UPDRS part III)
  • Stable antiparkinsonian medication for at least 4 weeks prior to study inclusion
  • Ability to provide informed consent

Exclusion Criteria:

  • Clinical signs for a secondary or atypical Parkinsonian syndrome
  • Treatment with any investigational medical product within 30 days prior to study inclusion
  • Intake of chocolate or other cocoa-containing products within the last 7 days prior to study inclusion (patients can be re-screened after 7 days of abstinence from chocolate and other cocoa-containing products)
  • Known intolerance or allergies against chocolate or other cocoa-containing products
  • Diabetes mellitus and/or impaired glucose tolerance in the medical history
  • Alcohol or drug abuse in the medical history
  • Presence of levodopa-induced motor complications
  • Other neurological, psychiatric or miscellaneous conditions that would significantly impair study participation, medical assessments or the consenting process
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275884


Contacts
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Contact: Matthias Löhle, MD + 49 351 458 2532 matthias.loehle@uniklinikum-dresden.de
Contact: Alexander Storch, MD + 49 351 458 2532 alexander.storch@uniklinikum-dresden.de

Locations
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Germany
Department of Neurology, Dresden University of Technology Recruiting
Dresden, Saxony, Germany, 01307
Contact: Simone Schmidt    +49 351 458 2524 ext 2524    simone.schmidt@uniklinikum-dresden.de   
Principal Investigator: Matthias Löhle, MD         
Sub-Investigator: Alexander Storch, MD         
Sponsors and Collaborators
Technische Universität Dresden
University of Wuerzburg
Investigators
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Principal Investigator: Matthias Löhle, MD Department of Neurology, Dresden University of Technology
More Information
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02275884    
Other Study ID Numbers: EK366112012
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Keywords provided by Technische Universität Dresden:
Parkinson Disease
Cacao
Biogenic amines
Xanthines
Neurodegenerative Diseases
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases