NCT03288155

Brief Summary

This study determines to evaluate the effectiveness of the daily consumption of flavonoid-rich cocoa in the treatment of fatigue in Parkinson's patients. The participants were divided equally between the flavonoid-rich cocoa (device) and control cocoa groups. The participant will engage in a six day trial, with measures taken at Day 1 and Day 6.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

September 15, 2017

Last Update Submit

September 4, 2019

Conditions

Parkinson DiseaseFatigue

Keywords

Parkinson'sFatigueFlavonoidCocoa

Outcome Measures

Primary Outcomes (1)

  • Fatigue Numerical Scale (FNS)

    The FFS measures the fatigue of an individual at set times throughout the day

    Change from Baseline to Day 6

Secondary Outcomes (5)

  • Adult Memory and Information Processing Battery (AMIPB)

    Measurements taken at baseline and Day 6

  • 6-Minute Walking Test

    Measurements taken at baseline and Day 6

  • Dietary Recall

    Measurements taken at baseline and Day 6

  • Accelerometer

    Measurements continuously taken from baseline to Day 6

  • Final Evaluation Interview

    Taken at day 6

Study Arms (2)

Flavonoid rich cocoa

EXPERIMENTAL

Dark cocoa beverage rich in flavonoids

Dietary Supplement: Cocoa

Low flavonoid cocoa

PLACEBO COMPARATOR

A control cocoa beverage low inn flavonoids

Dietary Supplement: Cocoa

Interventions

CocoaDIETARY_SUPPLEMENT

Participants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa.

Flavonoid rich cocoaLow flavonoid cocoa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years + with a clinical diagnosis of Parkinson's disease
  • Sufficient mental capacity to consent
  • Score of 1-2 on Hoehn and Yahr scale

You may not qualify if:

  • Change in medication before the previous week of the trial and/ or an expected change during
  • Known psychiatric disorder (clinically diagnosed)
  • Contraindications tolerating the cocoa drink
  • Other conditions that may be associated with fatigue, e.g. Anaemia
  • Condition affecting the central nervous system other than Parkinson's disease (however migraine is allowed)
  • Pregnant or lactating
  • Objection to contacting their GP and neurologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Parkinson Therapy Centre

Boario, Terme, 25041, Italy

Location

Related Publications (1)

  • Coe S, Andreoli D, George M, Collett J, Reed A, Cossington J, Izadi H, Dixon A, Mansoubi M, Dawes H. A feasibility study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue and fatigability in people with Parkinson's (pwP). Clin Nutr ESPEN. 2022 Apr;48:68-73. doi: 10.1016/j.clnesp.2022.01.023. Epub 2022 Jan 31.

    PMID: 35331536DERIVED

MeSH Terms

Conditions

Parkinson DiseaseFatigue

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Shelly A Coe, PhD

    Oxford Brookes Univeristy

    PRINCIPAL INVESTIGATOR

  • Alex Reed

    European Parkinson Therapy Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blind randomized controlled feasibility trial with assessors and participant blinded to intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 19, 2017

Study Start

July 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

IT(1)