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Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease (Choc-PD)

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dark chocolate (85% cocoa)
White chocolate (0% cocoa)
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Parkinson Disease, Cacao, Biogenic amines, Xanthines, Neurodegenerative Diseases

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Dresden University of TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Dark chocolate (85% cocoa)

White chocolate (0% cocoa)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in plasma concentrations of pharmacologically active constituents of chocolate after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Change in the severity of motor and non-motor symptoms of PD after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Changes in motor symptoms will be assessed with the UPDRS, changes in non-motor symptoms will be assessed with NMSS and NMSQuest.

Secondary Outcome Measures

Change in cognitive measures (MoCA, SCOPA-COG) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Change in depressive symptoms (BDI-II) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Change in the quality of life (PDQ-39) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate

Full Information

First Posted
October 17, 2014
Last Updated
October 23, 2014
Sponsor
Technische Universität Dresden
Collaborators
University of Wuerzburg
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1. Study Identification

Unique Protocol Identification Number
NCT02275884
Brief Title
Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease
Acronym
Choc-PD
Official Title
Evaluation of Plasma Concentrations of Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
University of Wuerzburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Cacao, Biogenic amines, Xanthines, Neurodegenerative Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dark chocolate (85% cocoa)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
White chocolate (0% cocoa)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dark chocolate (85% cocoa)
Intervention Type
Dietary Supplement
Intervention Name(s)
White chocolate (0% cocoa)
Primary Outcome Measure Information:
Title
Change in plasma concentrations of pharmacologically active constituents of chocolate after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Time Frame
7 days
Title
Change in the severity of motor and non-motor symptoms of PD after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Description
Changes in motor symptoms will be assessed with the UPDRS, changes in non-motor symptoms will be assessed with NMSS and NMSQuest.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Change in cognitive measures (MoCA, SCOPA-COG) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Time Frame
7 days
Title
Change in depressive symptoms (BDI-II) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Time Frame
7 days
Title
Change in the quality of life (PDQ-39) after one week consumption of dark chocolate in comparison to baseline and to one week consumption of white chocolate
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Löhle, MD
Phone
+ 49 351 458 2532
Email
matthias.loehle@uniklinikum-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Storch, MD
Phone
+ 49 351 458 2532
Email
alexander.storch@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Löhle, MD
Organizational Affiliation
Department of Neurology, Dresden University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Dresden University of Technology
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Schmidt
Phone
+49 351 458 2524
Ext
2524
Email
simone.schmidt@uniklinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Matthias Löhle, MD
First Name & Middle Initial & Last Name & Degree
Alexander Storch, MD

12. IPD Sharing Statement

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

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