Ketogenic Diets for Symptoms of Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01364545
First received: May 18, 2011
Last updated: June 1, 2011
Last verified: May 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    Difference between ketone versus placebo scores


Secondary Outcome Measures:
  • Timed motor tasks as per CAPSIT [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Hand/Arm movements, 7m walk, 9 hole peg test

  • Computerised reaction time and cogntive tests [ Time Frame: 5 days ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Difference between ketone versus placebo scores

  • Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   42 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 18, 2011
Last Updated: June 1, 2011
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 28, 2014