Ketogenic Diets for Symptoms of Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ketone ester drink
Placebo (carbohydrate containing) drink
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with Primary Parkinson's disease fulfilling UK Brain Bank criteria
- Age of onset of Parkinson's disease symptoms > 40 years old
- Duration of symptoms over 2 years
Exclusion Criteria:
- Dementia
- Active psychosis
- Deep brain stimulation or apomorphine infusion
- Severe motor fluctuations
- Significant metabolic or uncontrolled medical cormorbidity
Sites / Locations
- John Radcliffe HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ketone ester drink Vs placebo drink
Arm Description
Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both)
Outcomes
Primary Outcome Measures
Unified Parkinson's Disease rating Scale, part III (motor)
Difference between ketone versus placebo scores
Secondary Outcome Measures
Timed motor tasks as per CAPSIT
Hand/Arm movements, 7m walk, 9 hole peg test
Computerised reaction time and cogntive tests
CANTAB
SRT and CRT (Task: MOT "Motor screening" practice then RTI "Reaction time")
Spatial working memory (Task: SSP "spatial span")
Set shifting and visual discrimination (Task: BLC "big circle little circle" practice then IED "intra-extra dimensional shift)
Continuous performance task (alertness) (Task: RVP - "Rapid visual processing")
Unified Parkinson's disease rating scale, parts I, II, IV
Difference between ketone versus placebo scores
Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)
Difference between ketone versus placebo doses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01364545
Brief Title
Ketogenic Diets for Symptoms of Parkinson's Disease
Official Title
Ketogenic Diets for Symptoms of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oxford
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Parkinson's disease is a progressive condition that harms nerve cells of the brain (neurodegeneration). Current treatments for Parkinson's disease (including levodopa and deep brain stimulation) improve certain symptoms but are not thought to improve the underlying neurodegenerative disease process (they are not a "cure"). The cause of Parkinson's disease is unknown. However, some evidence suggests that tiny structures in the investigators cells called "mitochondria" might be involved. Mitochondria are the powerhouses that produce fuel for the investigators cells. Failure of these 'powerhouses' to supply the energy needs of certain nerve cells might lead to Parkinson's disease. Preliminary evidence suggests that a food called 'ketones' might be able to enhance the function of mitochondria and improve Parkinson's disease symptoms and possibly even the neurodegenerative process. In this study, the investigators would like to investigate this possibility by giving patients with Parkinson's disease dietary supplements of 'ketone esters' in a drink. The investigators will then assess if this improves symptoms of Parkinson's disease.
The study design is a prospective, double blinded, randomised, controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketone ester drink Vs placebo drink
Arm Type
Other
Arm Description
Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone ester drink
Intervention Description
Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (carbohydrate containing) drink
Intervention Description
Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease rating Scale, part III (motor)
Description
Difference between ketone versus placebo scores
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Timed motor tasks as per CAPSIT
Description
Hand/Arm movements, 7m walk, 9 hole peg test
Time Frame
5 days
Title
Computerised reaction time and cogntive tests
Description
CANTAB
SRT and CRT (Task: MOT "Motor screening" practice then RTI "Reaction time")
Spatial working memory (Task: SSP "spatial span")
Set shifting and visual discrimination (Task: BLC "big circle little circle" practice then IED "intra-extra dimensional shift)
Continuous performance task (alertness) (Task: RVP - "Rapid visual processing")
Time Frame
5 days
Title
Unified Parkinson's disease rating scale, parts I, II, IV
Description
Difference between ketone versus placebo scores
Time Frame
5 days
Title
Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)
Description
Difference between ketone versus placebo doses
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Primary Parkinson's disease fulfilling UK Brain Bank criteria
Age of onset of Parkinson's disease symptoms > 40 years old
Duration of symptoms over 2 years
Exclusion Criteria:
Dementia
Active psychosis
Deep brain stimulation or apomorphine infusion
Severe motor fluctuations
Significant metabolic or uncontrolled medical cormorbidity
Facility Information:
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX39DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wesley Thevathasan, FRACP
Email
wesley.thevathasan@nds.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Wesley Thevathasan, FRACP
12. IPD Sharing Statement
Learn more about this trial
Ketogenic Diets for Symptoms of Parkinson's Disease
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