Effects of Chocolate on Motor Symptoms of Parkinson's Disease

Parkinson's Disease Clinical Trial

— ChocoPD  

Official title:

Effects of Chocolate on Motor Symptoms of Parkinson's Disease - A Monocenter, Prospective, Observer-blinded Interventional Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00906763
• Other study ID #: EK284112008
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2009
• Last updated: May 25, 2010
• Start date: May 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2010
• Source: Technische Universität Dresden
• Contact: Martin Wolz, MD
• Phone: ++49-351-458
• Email: martin.wolz[@]neuro.med.tu-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Dietary Supplement:
• Chocolate
A single oral application of 200 grams of chocolate (85% cocoa for arm #1; 0% cocoa for arm #2).

Locations

Country	Name	City	State
Germany	Dresden University of Technology, Medical Faculty	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. doi: 10.1007/s00415-009-0118-9. Epub 2009 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS part III		1 h after intake of study intervention	No
Secondary	Biogenic amines in blood		1 to 3 h after study intervention	No