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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
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 20, 2009
Last Updated
May 25, 2010
Sponsor
Technische Universität Dresden
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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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