Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease

NCT ID: NCT02275884

Last Updated: 2014-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-06-30

Brief Summary

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This study evaluates plasma concentrations of pharmacologically active constituents of chocolate and their effects on motor and non-motor symptoms of Parkinson's disease. Following one week of abstinence from cocoa-containing products, patients with Parkinson's disease will be randomized to receive either dark or white chocolate. After one week of chocolate consumption, patients will then cross over to white or dark chocolate, respectively, and take the corresponding chocolate product for another week. Blood samples will be taken at baseline, week 1 and week 2 to examine plasma concentrations of pharmacologically active constituents of chocolate at all three timepoints. Moreover, patients will be clinically examined for motor and non-motor symptoms at all visits.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dark chocolate (85% cocoa)

Patients will initially receive 50 grams of dark chocolate (85% cocoa) b.i.d. for one week. Patients will then cross over to intake of 50 grams of white chocolate (0% cocoa) b.i.d. for another week.

Group Type ACTIVE_COMPARATOR

Dark chocolate (85% cocoa)

Intervention Type DIETARY_SUPPLEMENT

White chocolate (0% cocoa)

Intervention Type DIETARY_SUPPLEMENT

White chocolate (0% cocoa)

Patients will initially receive 50 grams of white chocolate (0% cocoa) b.i.d. for one week. Patients will then cross over to intake of 50 grams of dark chocolate (85% cocoa) b.i.d. for another week.

Group Type SHAM_COMPARATOR

Dark chocolate (85% cocoa)

Intervention Type DIETARY_SUPPLEMENT

White chocolate (0% cocoa)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Dark chocolate (85% cocoa)

Intervention Type DIETARY_SUPPLEMENT

White chocolate (0% cocoa)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Female or male individuals aged 40 years and above
* Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
* Hoehn and Yahr stage I-III
* Minimum score of 16 points in the motor part of the Unified Parkinson Disease Rating Scale (UPDRS part III)
* Stable antiparkinsonian medication for at least 4 weeks prior to study inclusion
* Ability to provide informed consent

Exclusion Criteria

* Clinical signs for a secondary or atypical Parkinsonian syndrome
* Treatment with any investigational medical product within 30 days prior to study inclusion
* Intake of chocolate or other cocoa-containing products within the last 7 days prior to study inclusion (patients can be re-screened after 7 days of abstinence from chocolate and other cocoa-containing products)
* Known intolerance or allergies against chocolate or other cocoa-containing products
* Diabetes mellitus and/or impaired glucose tolerance in the medical history
* Alcohol or drug abuse in the medical history
* Presence of levodopa-induced motor complications
* Other neurological, psychiatric or miscellaneous conditions that would significantly impair study participation, medical assessments or the consenting process
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wuerzburg

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Löhle, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Dresden University of Technology

Locations

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Department of Neurology, Dresden University of Technology

Dresden, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Matthias Löhle, MD

Role: CONTACT

+ 49 351 458 2532

Alexander Storch, MD

Role: CONTACT

+ 49 351 458 2532

Facility Contacts

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Simone Schmidt

Role: primary

+49 351 458 2524 ext. 2524

Other Identifiers

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EK366112012

Identifier Type: -

Identifier Source: org_study_id

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