Ketogenic Diets for Symptoms of Parkinson's Disease

NCT ID: NCT01364545

Last Updated: 2011-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Brief Summary

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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

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ketone ester drink Vs placebo drink

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

Group Type OTHER

Ketone ester drink

Intervention Type DIETARY_SUPPLEMENT

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

Placebo (carbohydrate containing) drink

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Ketone ester drink

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

Intervention Type DIETARY_SUPPLEMENT

Placebo (carbohydrate containing) drink

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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University of Oxford and the John Radcliffe Hospital, Oxford

Locations

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John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Wesley Thevathasan, FRACP

Role: primary

Other Identifiers

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10/H0606/74

Identifier Type: -

Identifier Source: org_study_id

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