Parkinson's Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKetone ester drink
Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)
DIETARY_SUPPLEMENTPlacebo (carbohydrate containing) drink
Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily
Sponsors
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease rating Scale, part III (motor) | 5 days | Difference between ketone versus placebo scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed motor tasks as per CAPSIT | 5 days | Hand/Arm movements, 7m walk, 9 hole peg test |
| Computerised reaction time and cogntive tests | 5 days | 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 | 5 days | Difference between ketone versus placebo scores |
| Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day) | 5 days | Difference between ketone versus placebo doses |
Countries
United Kingdom
Outcome results
None listed