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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02275884
• Date of registration: 17/10/2014
• Prospective Registration: No
• Primary sponsor: Technische Universität Dresden
• Public title: Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease Choc-PD
• Scientific title: Evaluation of Plasma Concentrations of Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease
• Date of first enrolment: June 2013
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02275884
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Matthias Löhle, MD

• Name: Simone Schmidt

• Name: Matthias Löhle, MD
• Affiliation: Department of Neurology, Dresden University of Technology

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Dietary Supplement: Dark chocolate (85% cocoa)

Dietary Supplement: White chocolate (0% cocoa)

Primary Outcome(s)

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]

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 [Time Frame: 7 days]

Secondary Outcome(s)

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]

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]

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]

Secondary ID(s)

EK366112012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Wuerzburg