NCT00906763

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 26, 2010

Status Verified

May 1, 2010

Enrollment Period

1.3 years

First QC Date

May 20, 2009

Last Update Submit

May 25, 2010

Conditions

Keywords

Parkinson's diseaseNeurodegenerative DisordersBiogenic aminesChocolateCocoa

Outcome Measures

Primary Outcomes (1)

  • UPDRS part III

    1 h after intake of study intervention

Secondary Outcomes (1)

  • Biogenic amines in blood

    1 to 3 h after study intervention

Study Arms (2)

Dark Chocolate (85% cocoa)

ACTIVE COMPARATOR

Oral Intake of dark chocolate (85% cocoa) over 15 minutes.

Dietary Supplement: Chocolate

White chocolate (0% cocoa)

ACTIVE COMPARATOR

Oral intake of 200 grams of white chocolate (0% cocoa) over 15 Minutes.

Dietary Supplement: Chocolate

Interventions

ChocolateDIETARY_SUPPLEMENT

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

Dark Chocolate (85% cocoa)White chocolate (0% cocoa)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 Years or older
  • Idiopathic Parkinson's disease, according to UKBB criteria
  • Hoehn \& Yahr Score II-III
  • 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

You may not qualify if:

  • Psychiatric conditions, severe enough to interfere with study procedures
  • motor or affective fluctuations or dyskinesias
  • treatment with COMT and/or MAO inhibitors
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dresden University of Technology, Medical Faculty

Dresden, 01307, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19277767BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseNeurodegenerative Diseases

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathies

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Martin Wolz, MD

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

May 1, 2009

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

May 26, 2010

Record last verified: 2010-05

Locations