Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease
NCT ID: NCT02275884
Last Updated: 2014-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2013-06-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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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.
Dark chocolate (85% cocoa)
White chocolate (0% cocoa)
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.
Dark chocolate (85% cocoa)
White chocolate (0% cocoa)
Interventions
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Dark chocolate (85% cocoa)
White chocolate (0% cocoa)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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University of Wuerzburg
OTHER
Technische Universität Dresden
OTHER
Responsible Party
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Principal Investigators
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Matthias Löhle, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Dresden University of Technology
Locations
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Department of Neurology, Dresden University of Technology
Dresden, Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EK366112012
Identifier Type: -
Identifier Source: org_study_id
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