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

• ClinicalTrials.gov Identifier: NCT02275884
• Recruitment Status: Unknown
• First Posted: October 27, 2014
• Last Update Posted: October 27, 2014
• Sponsor: Technische Universität Dresden
• Collaborator: University of Wuerzburg
• Information provided by (Responsible Party): Technische Universität Dresden

Tracking Information

• First Submitted Date: October 17, 2014
• First Posted Date: October 27, 2014
• Last Update Posted Date: October 27, 2014
• Study Start Date: June 2013
• Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2014)

• 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 ]
  Changes in motor symptoms will be assessed with the UPDRS, changes in non-motor symptoms will be assessed with NMSS and NMSQuest.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 23, 2014)

• 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 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease
• Official Title: Evaluation of Plasma Concentrations of Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Parkinson Disease

Intervention

• Dietary Supplement: Dark chocolate (85% cocoa)
• Dietary Supplement: White chocolate (0% cocoa)

Study Arms

• Active Comparator: 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.
  Interventions:

  • Dietary Supplement: Dark chocolate (85% cocoa)
  • Dietary Supplement: White chocolate (0% cocoa)
• Sham Comparator: 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.
  Interventions:

  • Dietary Supplement: Dark chocolate (85% cocoa)
  • Dietary Supplement: White chocolate (0% cocoa)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 23, 2014): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2015
• Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02275884
• Other Study ID Numbers: EK366112012
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Technische Universität Dresden
• Original Responsible Party: Same as current
• Current Study Sponsor: Technische Universität Dresden
• Original Study Sponsor: Same as current
• Collaborators: University of Wuerzburg

Investigators

• Principal Investigator: Matthias Löhle, MD; Department of Neurology, Dresden University of Technology

• PRS Account: Technische Universität Dresden
• Verification Date: October 2014