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

NCT02275884 | Unknown

• 1 other identifier: EK366112012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Cacao; Biogenic amines; Xanthines; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Dark chocolate (85% cocoa)

ACTIVE COMPARATOR

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.

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

White chocolate (0% cocoa)

SHAM COMPARATOR

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.

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

Interventions

Dark chocolate (85% cocoa) DIETARY_SUPPLEMENT

Dark chocolate (85% cocoa); White chocolate (0% cocoa)

White chocolate (0% cocoa) DIETARY_SUPPLEMENT

Dark chocolate (85% cocoa); White chocolate (0% cocoa)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Ability to provide informed consent

You may not qualify if:

• Clinical signs for a secondary or atypical Parkinsonian syndrome
• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• University of Wuerzburg: collaborator

Study Sites (1)

Department of Neurology, Dresden University of Technology

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Matthias Löhle, MD

  Department of Neurology, Dresden University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Löhle, MD

CONTACT

+ 49 351 458 2532; matthias.loehle@uniklinikum-dresden.de

Alexander Storch, MD

CONTACT

+ 49 351 458 2532; alexander.storch@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 27, 2014
• Study Start: June 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

DE (1)