Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Chocolate on Motor Symptoms of Parkinson's Disease (ChocoPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00906763
Recruitment Status : Unknown
Verified May 2010 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : May 21, 2009
Last Update Posted : May 26, 2010
Sponsor:
Information provided by:
Technische Universität Dresden

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 21, 2009
Last Update Posted Date May 26, 2010
Study Start Date  ICMJE May 2009
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2009)
UPDRS part III [ Time Frame: 1 h after intake of study intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00906763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2009)
Biogenic amines in blood [ Time Frame: 1 to 3 h after study intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Chocolate on Motor Symptoms of Parkinson's Disease
Official Title  ICMJE Effects of Chocolate on Motor Symptoms of Parkinson's Disease - A Monocenter, Prospective, Observer-blinded Interventional Trial
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Dietary Supplement: Chocolate
A single oral application of 200 grams of chocolate (85% cocoa for arm #1; 0% cocoa for arm #2).
Study Arms  ICMJE
  • Active Comparator: Dark Chocolate (85% cocoa)
    Oral Intake of dark chocolate (85% cocoa) over 15 minutes.
    Intervention: Dietary Supplement: Chocolate
  • Active Comparator: White chocolate (0% cocoa)
    Oral intake of 200 grams of white chocolate (0% cocoa) over 15 Minutes.
    Intervention: Dietary Supplement: Chocolate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 20, 2009)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2010
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00906763
Other Study ID Numbers  ICMJE EK284112008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Wolz, MD, Dresden University of Technology
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Wolz, MD Technische Universität Dresden
PRS Account Technische Universität Dresden
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP