Ketogenic Diets for Symptoms of Parkinson's Disease
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Dietary Supplement: Ketone ester drink Dietary Supplement: Placebo (carbohydrate containing) drink |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Ketogenic Diets for Symptoms of Parkinson's Disease |
- Unified Parkinson's Disease rating Scale, part III (motor) [ Time Frame: 5 days ] [ Designated as safety issue: No ]Difference between ketone versus placebo scores
- Timed motor tasks as per CAPSIT [ Time Frame: 5 days ] [ Designated as safety issue: No ]Hand/Arm movements, 7m walk, 9 hole peg test
- Computerised reaction time and cogntive tests [ Time Frame: 5 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 5 days ] [ Designated as safety issue: No ]Difference between ketone versus placebo scores
- Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day) [ Time Frame: 5 days ] [ Designated as safety issue: No ]Difference between ketone versus placebo doses
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Ketone ester drink Vs placebo drink
Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both)
|
Dietary Supplement: Ketone ester drink
Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)
Dietary Supplement: Placebo (carbohydrate containing) drink
Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily
|
Eligibility| Ages Eligible for Study: | 42 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01364545
| United Kingdom | |
| John Radcliffe Hospital | Recruiting |
| Oxford, Oxfordshire, United Kingdom, OX39DU | |
| Contact: Wesley Thevathasan, FRACP wesley.thevathasan@nds.ox.ac.uk | |
| Principal Investigator: Wesley Thevathasan, FRACP | |
More Information
No publications provided
| Responsible Party: | Dr Wesley Thevathasan, Honorary consultant neurologist, University of Oxford and the John Radcliffe Hospital, Oxford |
| ClinicalTrials.gov Identifier: | NCT01364545 History of Changes |
| Other Study ID Numbers: | 10/H0606/74 |
| Study First Received: | May 18, 2011 |
| Last Updated: | June 1, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on October 16, 2014