Parkinson DiseaseNCT04477161
Effect of Ketone Esters in Parkinson's Disease
A study testing Ketone Ester Elite endurance Nutrition Drink and Stool Sample in people with Parkinson Disease and Ketosis, run by University of Florida at 1 site in United States.
Trial summary
Ketones esters have shown to improve mitochondrial function and are currently use to enhanced functional performance. As Mitochondrial dysfunction is one of the proposed mechanism of neuronal injury in Parkinson's disease, the study aims to assess the tolerability,side effects and effect of oral ketone esters in… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease, Ketosis
- What is being tested?
- Ketone Ester Elite endurance Nutrition Drink and Stool Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 5 Nov 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-diagnosed Parkinson's Disease
- 40-75 years of age
- On stable dopaminergic therapy
- Willing and able to complete the informed consent form in English
- Willing to consume the study supplement four times each day during the 4-week intervention period
- Willing to complete all dietary recalls over approximately 6 weeks
- Willing to complete all daily and weekly questionnaires throughout the six weeks.
Who cannot join
- Does not meet the above criteria
- Atypical or secondary Parkinsonism
- BMI >30
- Rheumatological or other inflammatory conditions
- Following of the ketogenic diet
- History of ulcer disease
Show all 13Show fewer
- History of irritable bowel disorder or irritable bowel syndrome
- Currently taking any medication that could affect stool formation.
- Diagnosis of Diabetes mellitus Type 1 or Type 2
- Currently smoking (including vaping) tobacco products.
- Women who are lactating, know that they are pregnant, or are attempting to get pregnant.
- Note: a pregnancy test will be administered prior to initiating consumption of the study supplement. Women who are pregnant will be withdrawn from the study at that time.
- Use of another investigational product within 3 months of the initial visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
About this study
Official title: Effect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.
Ketones esters have shown to improve mitochondrial function and are currently use to enhanced functional performance. As Mitochondrial dysfunction is one of the proposed mechanism of neuronal injury in Parkinson's disease, the study aims to assess the tolerability,side effects and effect of oral ketone esters in Patients with Parkinson's disease.
Read the detailed description
Parkinson's Disease (PD) is a debilitating progressive neurodegenerative disorder, second in frequency only to Alzheimer's disease, affecting around 10 million people worldwide. PD is characterized by loss of dopaminergic cells in substantia nigra and the accumulation of Lewy bodies. There is no disease modifying treatment or cure for the disease and management strategies focus on symptomatic treatment. One of the proposed mechanisms for the dopaminergic neurons degeneration in sporadic Parkinson's disease cases is related to compromise cellular bioenergetics, resulting in excessive production of reactive oxygen species (ROS) that leads to oxidative stress. Numerous studies have identified mitochondrial dysfunction as the central pathological features of both genetic and sporadic PD. Mitochondrial dysfunction can also increase inflammation which is associated with PD and Lewy Body formation. Elevated plasma ketones have been shown to enhance energy reserves, ATP levels and the expression of many enzymes involved in multiple metabolic pathways in the mitochondria. This pilot study aims to assess the effect of an exogenous ketone supplement on functional performance in people with PD. Changes in inflammatory makers will also be assessed. Participants will ingest the exogenous ketone supplement four times per day for four weeks. Participants will undergo neurological, functional, and cognitive assessments prior to and after the four-week intervention. Dietitians will follow up with participants weekly for compliance and counseling. Diet will be assessed throughout the study using the automated self-administered 24-hour dietary recall. After the four week intervention, a two-week "washout" period will be observed before reassessing functional and cognitive performance again.
Additionally, the study would like to establish the extent to which the use of Ketone esters impact the gut microbiota. Gut microbita composition in PD has been associated with symptoms and treatment efficacy.
- Conditions
- Parkinson Disease, Ketosis
- Being tested
- Ketone Ester Elite endurance Nutrition Drink, Stool Sample
- Keywords
- parkinson disease, ketosis, microbiota
- Medical subject headings
- Parkinson Disease, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Ester Elite endurance Nutrition DrinkDietary supplement
Subjects will take one bottle four times daily for four weeks
Stool SampleOther
Subjects will provide a stool sample at 2 timepoints.
| Study group | Role | What they receive |
|---|---|---|
| Ketone Intervention | Experimental | Subjects will take the Ketone Ester Elite Endurance Nutrition Drink. They will drink 1 bottle 4 times daily for 4 weeks Receives: Dietary Supplement: Ketone Ester Elite endurance Nutrition Drink; Other: Stool Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum Ketones
by measuring the beta-hydroxybutyrate/serum glucose levels in blood at baseline and four months
Measured: Baseline up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start5 Sep 2019
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot, prospective, single-arm, single-center study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477161
- Sponsor's protocol ID
- Ketone in PD
- Other IDs
- IRB201901326, OCR24402
- Status last verified
- Jan 2022
- First submitted
- 22 Jun 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be shared with collaborators on project here at the University of Florida and only de-identified data will be released with IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.
- ClinicalTrials.gov ID
- NCT04477161
- Acronym / sponsor ID
- Ketone in PD
- Conditions
- Parkinson Disease, Ketosis
- Keywords
- parkinson disease, ketosis, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 20 Jul 2020 (actual)
- 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.
Ketones esters have shown to improve mitochondrial function and are currently use to enhanced functional performance. As Mitochondrial dysfunction is one of the proposed mechanism of neuronal injury in Parkinson's disease, the study aims to assess the tolerability,side effects and effect of oral ketone esters in Patients with Parkinson's disease.
Detailed description
Parkinson's Disease (PD) is a debilitating progressive neurodegenerative disorder, second in frequency only to Alzheimer's disease, affecting around 10 million people worldwide. PD is characterized by loss of dopaminergic cells in substantia nigra and the accumulation of Lewy bodies. There is no disease modifying treatment or cure for the disease and management strategies focus on symptomatic treatment. One of the proposed mechanisms for the dopaminergic neurons degeneration in sporadic Parkinson's disease cases is related to compromise cellular bioenergetics, resulting in excessive production of reactive oxygen species (ROS) that leads to oxidative stress. Numerous studies have identified mitochondrial dysfunction as the central pathological features of both genetic and sporadic PD. Mitochondrial dysfunction can also increase inflammation which is associated with PD and Lewy Body formation. Elevated plasma ketones have been shown to enhance energy reserves, ATP levels and the expression of many enzymes involved in multiple metabolic pathways in the mitochondria. This pilot study aims to assess the effect of an exogenous ketone supplement on functional performance in people with PD. Changes in inflammatory makers will also be assessed. Participants will ingest the exogenous ketone supplement four times per day for four weeks. Participants will undergo neurological, functional, and cognitive assessments prior to and after the four-week intervention. Dietitians will follow up with participants weekly for compliance and counseling. Diet will be assessed throughout the study using the automated self-administered 24-hour dietary recall. After the four week intervention, a two-week "washout" period will be observed before reassessing functional and cognitive performance again.
Additionally, the study would like to establish the extent to which the use of Ketone esters impact the gut microbiota. Gut microbita composition in PD has been associated with symptoms and treatment efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot, prospective, single-arm, single-center study
| Arm | Type | Receives |
|---|---|---|
| Ketone Intervention | Experimental | Dietary Supplement: Ketone Ester Elite endurance Nutrition Drink, Other: Stool SampleSubjects will take the Ketone Ester Elite Endurance Nutrition Drink. They will drink 1 bottle 4 times daily for 4 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Physician-diagnosed Parkinson's Disease
- 40-75 years of age
- On stable dopaminergic therapy
- Willing and able to complete the informed consent form in English
- Willing to consume the study supplement four times each day during the 4-week intervention period
Key exclusion criteria (13 listed)
- Does not meet the above criteria
- Atypical or secondary Parkinsonism
- BMI >30
- Rheumatological or other inflammatory conditions
- Following of the ketogenic diet
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 Elite endurance Nutrition DrinkSubjects will take one bottle four times daily for four weeks | Dietary supplement | Ketone Intervention |
| Stool SampleSubjects will provide a stool sample at 2 timepoints. | Other | Ketone Intervention |
Primary outcome
Changes in serum Ketones
Time frame: Baseline up to 4 months
by measuring the beta-hydroxybutyrate/serum glucose levels in blood at baseline and four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No. Participant data will be shared with collaborators on project here at the University of Florida and only de-identified data will be released with IRB approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Elite endurance Nutrition Drink and Stool Sample in people with Parkinson Disease and Ketosis, run by University of Florida at 1 site in United States.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 4 Jan 2022. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum Ketones (time frame: Baseline up to 4 months). 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 4 Jan 2022.