Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Plasma Concentrations of Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: Dark chocolate (85% cocoa)
* Dietary Supplement: White chocolate (0% cocoa)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dark chocolate (85% cocoa)<br>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)<br> <br> Dietary Supplement: White chocolate (0% cocoa)<br> <br> |
| Sham Comparator: White chocolate (0% cocoa)<br>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)<br> <br> Dietary Supplement: White chocolate (0% cocoa)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Cacao, Biogenic amines, Xanthines, Neurodegenerative Diseases