Effects of Chocolate on Motor Symptoms of Parkinson's Disease (ChocoPD)
Recruitment status was Recruiting
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Dietary Supplement: Chocolate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Chocolate on Motor Symptoms of Parkinson's Disease - A Monocenter, Prospective, Observer-blinded Interventional Trial |
- UPDRS part III [ Time Frame: 1 h after intake of study intervention ] [ Designated as safety issue: No ]
- Biogenic amines in blood [ Time Frame: 1 to 3 h after study intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 23 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dark Chocolate (85% cocoa)
Oral Intake of dark chocolate (85% cocoa) over 15 minutes.
|
Dietary Supplement: Chocolate
A single oral application of 200 grams of chocolate (85% cocoa for arm #1; 0% cocoa for arm #2).
|
|
Active Comparator: White chocolate (0% cocoa)
Oral intake of 200 grams of white chocolate (0% cocoa) over 15 Minutes.
|
Dietary Supplement: Chocolate
A single oral application of 200 grams of chocolate (85% cocoa for arm #1; 0% cocoa for arm #2).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age of 18 Years or older
- Idiopathic Parkinson's disease, according to UKBB criteria
- Hoehn & Yahr Score II-III
- 16 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
- Stable antiparkinsonian medication for at least 4 weeks prior to study inclusion
Exclusion Criteria:
- Psychiatric conditions, severe enough to interfere with study procedures
- motor or affective fluctuations or dyskinesias
- treatment with COMT and/or MAO inhibitors
- Diabetes mellitus
Contacts and Locations| Contact: Martin Wolz, MD | ++49-351-458 ext 3106 | martin.wolz@neuro.med.tu-dresden.de |
| Contact: Alexander Storch, MD | ++49-351-458 ext 2532 | alexander.storch@neuro.med.tu-dresden.de |
| Germany | |
| Dresden University of Technology, Medical Faculty | Recruiting |
| Dresden, Germany, 01307 | |
| Contact: Simone Schmidt ++49-351-458 ext 2524 simone.schmidt@neuro.med.tu-dresden.de | |
| Principal Investigator: Martin Wolz, MD | |
| Sub-Investigator: Alexander Storch, MD | |
| Sub-Investigator: Christine Schneider, MD | |
| Sub-Investigator: Lisa Klingelhöfer, MD | |
| Sub-Investigator: Susann Junghanns, MD | |
| Principal Investigator: | Martin Wolz, MD | Dresden University of Technology |
More Information
Publications:
| Responsible Party: | Martin Wolz, MD, Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT00906763 History of Changes |
| Other Study ID Numbers: | EK284112008 |
| Study First Received: | May 20, 2009 |
| Last Updated: | May 25, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Dresden University of Technology:
|
Parkinson's disease Neurodegenerative Disorders Biogenic amines Chocolate Cocoa |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 16, 2013