Ketogenic Diets for Symptoms of Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Ketogenic Diets for Symptoms of Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Dietary Supplement: Ketone ester drink
* Dietary Supplement: Placebo (carbohydrate containing) drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ketone ester drink Vs placebo drink<br>Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both) | Dietary Supplement: Ketone ester drink<br>* Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)<br>Dietary Supplement: Placebo (carbohydrate containing) drink<br>* Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease rating Scale, part III (motor) | Difference between ketone versus placebo scores | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed motor tasks as per CAPSIT | Hand/Arm movements, 7m walk, 9 hole peg test | 5 days | 
| 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) | 5 days | 
| Unified Parkinson's disease rating scale, parts I, II, IV | Difference between ketone versus placebo scores | 5 days | 
| Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day) | Difference between ketone versus placebo doses | 5 days |