Ketogenic Diets for Symptoms of Parkinson's Disease

June 1, 2011 updated by: University of Oxford

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX39DU
        • Recruiting
        • John Radcliffe Hospital
        • Contact:
        • Principal Investigator:
          • Wesley Thevathasan, FRACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

42 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease rating Scale, part III (motor)
Time Frame: 5 days
Difference between ketone versus placebo scores
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed motor tasks as per CAPSIT
Time Frame: 5 days
Hand/Arm movements, 7m walk, 9 hole peg test
5 days
Computerised reaction time and cogntive tests
Time Frame: 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")
5 days
Unified Parkinson's disease rating scale, parts I, II, IV
Time Frame: 5 days
Difference between ketone versus placebo scores
5 days
Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)
Time Frame: 5 days
Difference between ketone versus placebo doses
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (ESTIMATE)

June 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2011

Last Update Submitted That Met QC Criteria

June 1, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/H0606/74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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