Effects of Chocolate on Motor Symptoms of Parkinson's Disease (ChocoPD)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 20, 2009 | ||||||||
| Last Updated Date | May 25, 2010 | ||||||||
| Start Date ICMJE | May 2009 | ||||||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
UPDRS part III [ Time Frame: 1 h after intake of study intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00906763 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Biogenic amines in blood [ Time Frame: 1 to 3 h after study intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Chocolate on Motor Symptoms of Parkinson's Disease | ||||||||
| Official Title ICMJE | Effects of Chocolate on Motor Symptoms of Parkinson's Disease - A Monocenter, Prospective, Observer-blinded Interventional Trial | ||||||||
| 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). |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Parkinson's Disease | ||||||||
| Intervention ICMJE | Dietary Supplement: Chocolate
A single oral application of 200 grams of chocolate (85% cocoa for arm #1; 0% cocoa for arm #2). |
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| Study Arm (s) |
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| Publications * | Wolz M, Kaminsky A, Löhle 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. Epub 2009 Mar 13. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 23 | ||||||||
| Estimated Completion Date | October 2010 | ||||||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00906763 | ||||||||
| Other Study ID Numbers ICMJE | EK284112008 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Martin Wolz, MD, Dresden University of Technology | ||||||||
| Study Sponsor ICMJE | Dresden University of Technology | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Dresden University of Technology | ||||||||
| Verification Date | May 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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