Effects of Chocolate on Motor Symptoms of Parkinson's Disease (ChocoPD)
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Chocolate
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Neurodegenerative Disorders, Biogenic amines, Chocolate, Cocoa
Eligibility Criteria
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
Sites / Locations
- Dresden University of Technology, Medical FacultyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dark Chocolate (85% cocoa)
White chocolate (0% cocoa)
Arm Description
Oral Intake of dark chocolate (85% cocoa) over 15 minutes.
Oral intake of 200 grams of white chocolate (0% cocoa) over 15 Minutes.
Outcomes
Primary Outcome Measures
UPDRS part III
Secondary Outcome Measures
Biogenic amines in blood
Full Information
NCT ID
NCT00906763
First Posted
May 20, 2009
Last Updated
May 25, 2010
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT00906763
Brief Title
Effects of Chocolate on Motor Symptoms of Parkinson's Disease
Acronym
ChocoPD
Official Title
Effects of Chocolate on Motor Symptoms of Parkinson's Disease - A Monocenter, Prospective, Observer-blinded Interventional Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Neurodegenerative Disorders, Biogenic amines, Chocolate, Cocoa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dark Chocolate (85% cocoa)
Arm Type
Active Comparator
Arm Description
Oral Intake of dark chocolate (85% cocoa) over 15 minutes.
Arm Title
White chocolate (0% cocoa)
Arm Type
Active Comparator
Arm Description
Oral intake of 200 grams of white chocolate (0% cocoa) over 15 Minutes.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chocolate
Intervention Description
A single oral application of 200 grams of chocolate (85% cocoa for arm #1; 0% cocoa for arm #2).
Primary Outcome Measure Information:
Title
UPDRS part III
Time Frame
1 h after intake of study intervention
Secondary Outcome Measure Information:
Title
Biogenic amines in blood
Time Frame
1 to 3 h after study intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Wolz, MD
Phone
++49-351-458
Ext
3106
Email
martin.wolz@neuro.med.tu-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Storch, MD
Phone
++49-351-458
Ext
2532
Email
alexander.storch@neuro.med.tu-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Wolz, MD
Organizational Affiliation
Technische Universität Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dresden University of Technology, Medical Faculty
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Schmidt
Phone
++49-351-458
Ext
2524
Email
simone.schmidt@neuro.med.tu-dresden.de
First Name & Middle Initial & Last Name & Degree
Martin Wolz, MD
First Name & Middle Initial & Last Name & Degree
Alexander Storch, MD
First Name & Middle Initial & Last Name & Degree
Christine Schneider, MD
First Name & Middle Initial & Last Name & Degree
Lisa Klingelhöfer, MD
First Name & Middle Initial & Last Name & Degree
Susann Junghanns, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19277767
Citation
Wolz M, Kaminsky A, Lohle 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.
Results Reference
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Effects of Chocolate on Motor Symptoms of Parkinson's Disease
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