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

Parkinson Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275884
• Other study ID #: EK366112012
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: October 23, 2014
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2014
• Source: Technische Universität Dresden
• Contact: Matthias Löhle, MD
• Phone: + 49 351 458 2532
• Email: matthias.loehle[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Dietary Supplement:
• Dark chocolate (85% cocoa)

• White chocolate (0% cocoa)

Locations

Country	Name	City	State
Germany	Department of Neurology, Dresden University of Technology	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		7 days	No
Primary	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.	7 days	No
Secondary	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		7 days	No
Secondary	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		7 days	No
Secondary	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		7 days	No