Parkinson's DiseaseNCT01364545
Ketogenic Diets for Symptoms of Parkinson's Disease
A study testing Ketone ester drink in people with Parkinson's Disease, run by University of Oxford at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 42 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Ketone ester drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia
- Active psychosis
- Deep brain stimulation or apomorphine infusion
- Severe motor fluctuations
- Significant metabolic or uncontrolled medical cormorbidity
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX39DU
Wesley Thevathasan, FRACP, wesley.thevathasan@nds.ox.ac.uk
Wesley Thevathasan, FRACP
About this study
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.
- Conditions
- Parkinson's Disease
- Being tested
- Ketone ester drink, Placebo (carbohydrate containing) drink
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone ester drinkDietary supplement
Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)
Placebo (carbohydrate containing) drinkDietary supplement
Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily
| Study group | Role | What they receive |
|---|---|---|
| Ketone ester drink Vs placebo drink | Other | Ketone ester drink Vs placebo drink (cross over study - all patients will recieve both) Receives: Dietary Supplement: Ketone ester drink; Dietary Supplement: Placebo (carbohydrate containing) drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease rating Scale, part III (motor)
Difference between ketone versus placebo scores
Measured: 5 days
Secondary outcomes (4)
Timed motor tasks as per CAPSIT
Hand/Arm movements, 7m walk, 9 hole peg test
Measured: 5 days
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")
Measured: 5 days
Unified Parkinson's disease rating scale, parts I, II, IV
Difference between ketone versus placebo scores
Measured: 5 days
Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)
Difference between ketone versus placebo doses
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364545
- Sponsor's protocol ID
- 10/H0606/74
- Status last verified
- May 2011
- First submitted
- 18 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diets for Symptoms of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01364545
- Acronym / sponsor ID
- 10/H0606/74
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketone ester drink Vs placebo drink | Other | Dietary Supplement: Ketone ester drink, Dietary Supplement: Placebo (carbohydrate containing) drinkKetone ester drink Vs placebo drink (cross over study - all patients will recieve both) |
Who may qualify
- Ages
- 42 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Dementia
- Active psychosis
- Deep brain stimulation or apomorphine infusion
- Severe motor fluctuations
- Significant metabolic or uncontrolled medical cormorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone ester drinkKetone drink - milligram per kilogram dose, consumed three times daily (at meal times) | Dietary supplement | Ketone ester drink Vs placebo drink |
| Placebo (carbohydrate containing) drinkPlacebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily | Dietary supplement | Ketone ester drink Vs placebo drink |
Primary outcome
Unified Parkinson's Disease rating Scale, part III (motor)
Time frame: 5 days
Difference between ketone versus placebo scores
4 secondary outcomes
Timed motor tasks as per CAPSIT
Time frame: 5 days
Computerised reaction time and cogntive tests
Time frame: 5 days
Unified Parkinson's disease rating scale, parts I, II, IV
Time frame: 5 days
Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone ester drink in people with Parkinson's Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease rating Scale, part III (motor) (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.