Ketogenic Diets for Symptoms of Parkinson's Disease
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedJune 2, 2011
May 1, 2011
1 year
May 18, 2011
June 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Unified Parkinson's Disease rating Scale, part III (motor)
Difference between ketone versus placebo scores
5 days
Secondary Outcomes (4)
Timed motor tasks as per CAPSIT
5 days
Computerised reaction time and cogntive tests
5 days
Unified Parkinson's disease rating scale, parts I, II, IV
5 days
Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)
5 days
Study Arms (1)
Ketone ester drink Vs placebo drink
OTHERKetone ester drink Vs placebo drink (cross over study - all patients will recieve both)
Interventions
Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)
Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Dementia
- Active psychosis
- Deep brain stimulation or apomorphine infusion
- Severe motor fluctuations
- Significant metabolic or uncontrolled medical cormorbidity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John Radcliffe Hospital
Oxford, Oxfordshire, OX39DU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 18, 2011
First Posted
June 2, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2012
Last Updated
June 2, 2011
Record last verified: 2011-05