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Ketogenic Diets for Symptoms of Parkinson's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by University of Oxford.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364545
First Posted: June 2, 2011
Last Update Posted: June 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oxford
  Purpose

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.


Condition Intervention
Parkinson's Disease Dietary Supplement: Ketone ester drink Dietary Supplement: Placebo (carbohydrate containing) drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketogenic Diets for Symptoms of Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Unified Parkinson's Disease rating Scale, part III (motor) [ Time Frame: 5 days ]
    Difference between ketone versus placebo scores


Secondary Outcome Measures:
  • Timed motor tasks as per CAPSIT [ Time Frame: 5 days ]
    Hand/Arm movements, 7m walk, 9 hole peg test

  • 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")

  • Unified Parkinson's disease rating scale, parts I, II, IV [ Time Frame: 5 days ]
    Difference between ketone versus placebo scores

  • Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day) [ Time Frame: 5 days ]
    Difference between ketone versus placebo doses


Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364545


Locations
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX39DU
Contact: Wesley Thevathasan, FRACP       wesley.thevathasan@nds.ox.ac.uk   
Principal Investigator: Wesley Thevathasan, FRACP         
Sponsors and Collaborators
University of Oxford
  More Information

Responsible Party: Dr Wesley Thevathasan, Honorary consultant neurologist, University of Oxford and the John Radcliffe Hospital, Oxford
ClinicalTrials.gov Identifier: NCT01364545     History of Changes
Other Study ID Numbers: 10/H0606/74
First Submitted: May 18, 2011
First Posted: June 2, 2011
Last Update Posted: June 2, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases