Effects of Chocolate on Motor Symptoms of Parkinson's Disease
ChocoPD
1 other identifier
interventional
23
1 country
1
Brief Summary
Chocolate consumption has long been associated with enjoyment and pleasure. Popular claims confer on chocolate the properties of being a stimulant, relaxant, euphoriant and antidepressant. These possible pharmacological actions might be related to various biogenic amines, such as serotonin, dopamine, tyramine, histamine, phenylethylamine and cannabinoid-like substances. Most amines are metabolized by monoamineoxidase-A (MAO-A) and are therefore unable to pass the blood-brain-barrier. In contrast, phenylethylamine is a direct dopamine releasing ingredient and as a substrate of MAO-B and due to its lipophilic structure even capable to pass the blood-brain-barrier. Within this line, own clinical observations suggested an increased chocolate consumption in patients with Parkinson's disease (PD) compared to healthy subjects and to their pre-disease state. In a previous study, we assessed the consumption of chocolate and non-chocolate sweets in PD patients and their partners (as household controls) using a self-questionnaire. Consumption of chocolate was significantly higher in PD patients compared to controls, while consumption of non-chocolate sweets was similar in both groups. Our study suggests that chocolate consumption is increased in PD independent of concomitant depressive symptoms measured by BDI-1. Although reasons for increased chocolate consumption in PD remain elusive, it may hypothetically be a consequence of the high content of various biogenic amines as a content of cocoa influencing dopamine metabolism. Therefore, in the present study we aim to study the effects of dark chocolate with high cocoa content (85%) compared to chocolate without any cocoa (white chocolate) on motor symptoms in PD patients as measured with UPDRS part III (motor score). The principle design of the intervention is similar to the standard pharmacological challenge test for studying effects on motor symptoms in PD (e.g. levodopa challenge test).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMay 26, 2010
May 1, 2010
1.3 years
May 20, 2009
May 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
UPDRS part III
1 h after intake of study intervention
Secondary Outcomes (1)
Biogenic amines in blood
1 to 3 h after study intervention
Study Arms (2)
Dark Chocolate (85% cocoa)
ACTIVE COMPARATOROral Intake of dark chocolate (85% cocoa) over 15 minutes.
White chocolate (0% cocoa)
ACTIVE COMPARATOROral intake of 200 grams of white chocolate (0% cocoa) over 15 Minutes.
Interventions
A single oral application of 200 grams of chocolate (85% cocoa for arm #1; 0% cocoa for arm #2).
Eligibility Criteria
You may qualify if:
- Age of 18 Years or older
- Idiopathic Parkinson's disease, according to UKBB criteria
- Hoehn \& Yahr Score II-III
- Points or more in UPDRS part III scale
- Sufficient ability to follow the study procedure for at least 3 hours
- Ability to give informed consent
You may not qualify if:
- Psychiatric conditions, severe enough to interfere with study procedures
- motor or affective fluctuations or dyskinesias
- treatment with COMT and/or MAO inhibitors
- Diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dresden University of Technology, Medical Faculty
Dresden, 01307, Germany
Related Publications (1)
Wolz M, Kaminsky A, Lohle M, Koch R, Storch A, Reichmann H. Chocolate consumption is increased in Parkinson's disease. Results from a self-questionnaire study. J Neurol. 2009 Mar;256(3):488-92. doi: 10.1007/s00415-009-0118-9. Epub 2009 Mar 13.
PMID: 19277767BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Wolz, MD
Technische Universität Dresden
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 21, 2009
Study Start
May 1, 2009
Primary Completion
August 1, 2010
Study Completion
October 1, 2010
Last Updated
May 26, 2010
Record last verified: 2010-05