Ketogenic Diets for Symptoms of Parkinson's Disease

Ketogenic Diets for Symptoms of Parkinson's Disease

Sponsors

Lead sponsor: University of Oxford

Source University of Oxford
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.

Overall Status Unknown status
Start Date May 2011
Primary Completion Date May 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Unified Parkinson's Disease rating Scale, part III (motor) 5 days
Secondary Outcome
Measure Time Frame
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
Enrollment 20
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Ketone ester drink

Description: Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)

Arm group label: Ketone ester drink Vs placebo drink

Intervention type: Dietary Supplement

Intervention name: Placebo (carbohydrate containing) drink

Description: Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily

Arm group label: Ketone ester drink Vs placebo drink

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

Gender: All

Minimum age: 42 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility status contact investigator John Radcliffe Hospital Wesley Thevathasan, FRACP [email protected] Wesley Thevathasan, FRACP Principal Investigator
Location Countries

United Kingdom

Verification Date

May 2011

Responsible Party

Name title: Dr Wesley Thevathasan, Honorary consultant neurologist

Organization: University of Oxford and the John Radcliffe Hospital, Oxford

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Ketone ester drink Vs placebo drink

Arm group type: Other

Description: Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both)

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov