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| Name | Class |
|---|---|
| University of Wuerzburg | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dark chocolate (85% cocoa) | Active Comparator | 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. |
|
| White chocolate (0% cocoa) | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dark chocolate (85% cocoa) | Dietary Supplement |
| ||
| White chocolate (0% cocoa) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days | |
| 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 | Changes in motor symptoms will be assessed with the UPDRS, changes in non-motor symptoms will be assessed with NMSS and NMSQuest. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias Löhle, MD | Contact | + 49 351 458 2532 | matthias.loehle@uniklinikum-dresden.de | |
| Alexander Storch, MD | Contact | + 49 351 458 2532 | alexander.storch@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Matthias Löhle, MD | Department of Neurology, Dresden University of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Dresden University of Technology | Recruiting | Dresden | Saxony | 01307 | Germany |
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| Dietary Supplement |
|
| 7 days |
| 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 | 7 days |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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