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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00906763
First received: May 20, 2009
Last updated: May 25, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • UPDRS part III [ Time Frame: 1 h after intake of study intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906763

Contacts
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

Locations
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         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Martin Wolz, MD Technische Universität Dresden
  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 Technische Universität Dresden:
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 September 16, 2014