Ketogenic Diets for Symptoms of Parkinson's Disease

Not Applicable

• Conditions: Parkinson's Disease
• Interventions: Dietary Supplement: Ketone ester drink; Dietary Supplement: Placebo (carbohydrate containing) drink

• Registration Number: NCT01364545
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-05
• Study Start: 2011-05
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-06-01
• Last Update Submitted: 2011-06-01
• Study First Posted: 2011-06-02
• Last Update Posted: 2011-06-02
• Primary Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketone ester drink Vs placebo drink	Ketone ester drink	Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both)
Ketone ester drink Vs placebo drink	Placebo (carbohydrate containing) drink	Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both)

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease rating Scale, part III (motor)	5 days	Difference between ketone versus placebo scores

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom