ChocoPD: Effects of Chocolate on Motor Symptoms of Parkinson's Disease

Sponsor

Technische Universität Dresden (Other)

Overall Status

Unknown status

CT.gov ID

NCT00906763

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Dietary Supplement: Chocolate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Effects of Chocolate on Motor Symptoms of Parkinson's Disease - A Monocenter, Prospective, Observer-blinded Interventional Trial

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2010

Anticipated Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

UPDRS part III [1 h after intake of study intervention]

Secondary Outcome Measures

Biogenic amines in blood [1 to 3 h after study intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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