Ketogenic Diets for Symptoms of Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Ketogenic Diets for Symptoms of Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01364545
• Other study ID #: 10/H0606/74
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2011
• Last updated: June 1, 2011
• Start date: May 2011

Study information

• Verified date: May 2011
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 42 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Dietary Supplement:
• Ketone ester drink
Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)
• Placebo (carbohydrate containing) drink
Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease rating Scale, part III (motor)	Difference between ketone versus placebo scores	5 days	No
Secondary	Timed motor tasks as per CAPSIT	Hand/Arm movements, 7m walk, 9 hole peg test	5 days	No
Secondary	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	No
Secondary	Unified Parkinson's disease rating scale, parts I, II, IV	Difference between ketone versus placebo scores	5 days	No
Secondary	Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)	Difference between ketone versus placebo doses	5 days	No