Parkinson DiseaseNCT05778695

Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

A study testing Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate in people with Parkinson Disease and Lewy Body Dementia, run by University of Michigan at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Small exploratory open-label pilot study to assess supplementation of a ketone ester (KetoneAid) as a potential therapy for persons with Parkinson disease (PD), Parkinson Disease Dementia/Lewy Body Dementia (PDD/LBD), and healthy controls. Read more about this study

Who is it for?: Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for: Parkinson Disease, Lewy Body Dementia, Parkinson Disease Dementia
What is being tested?: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: 9 Mar 2023to 4 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy control volunteers over 45 years of age
People with Parkinson Disease over 45 years of age
People with Parkinson's Disease Dementia or Lewy Body Dementia over 45 years of age

Who cannot join

Participants with contra-indications to MR imaging, including pacemakers or claustrophobia;
Evidence of large vessel stroke or mass lesion on MRI
Regular use of anti-cholinergic, benzodiazepines, high dose (>100mg QD) of quetiapine, or neuroleptic drugs
History of significant GI disease
Significant metabolic or uncontrolled medical comorbidity
Poorly controlled diabetes

Show all 9Show fewer

Pregnancy or breast feeding
Current excessive alcohol use
Suicidal ideation

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Domino's Farms
Ann Arbor, Michigan, 48105
University Hospital
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Read the detailed description

The overarching goal of this study is to investigate glucose metabolic, cognitive, clinical and imaging changes in persons with PD and PDD/LBD before and after a month supplementation of a ketone ester (KetoneAid) in a small open label exploratory clinical trial. Positive findings in this small exploratory pilot trial may support future target engagement studies of ketone supplementation in PD and normal adults.

Conditions: Parkinson Disease, Lewy Body Dementia, Parkinson Disease Dementia
Being tested: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate
Keywords: ketone ester, ketosis, functional neuroimaging
Medical subject headings: Parkinson Disease, Lewy Body Disease, Ketosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketone Ester (R)-3-Hydroxybutyl (R)-3-HydroxybutyrateDietary supplement
Also called KetoneAid
Ketone ester (KE) dietary supplement (KetoneAid)

Study groups in NCT05778695
Study group	Role	What they receive
Parkinson Disease	Experimental	Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Receives: Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate
Parkinson Disease Dementia/Lewy Body Dementia	Experimental	Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary. Receives: Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate
Healthy Controls	Experimental	Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary. Receives: Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose Metabolism
Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the ketone ester in patients with PD, Parkinson's disease dementia/Lewy body dementia, and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL within 2 hours of eating meals.
Measured: Pre and post approximately 30 days of intervention
Clinical Dementia Rating Scale Score
The clinical dementia rating scale is a measure of functional and cognitive performance relevant to dementia. It is scored from 0 (normal) to 3 (severe dementia). The clinical dementia rating scale will be assessed in patients with Parkinson's disease, Parkinson's disease dementia/Lewy body dementia, and healthy controls before and after open-label treatment with the ketone ester.
Measured: Pre and post approximately 30 days of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20234 Oct 2023

First posted21 Mar 2023
Study start9 Mar 2023
Primary completion4 Oct 2023
Study completion4 Oct 2023

Why it stopped: Withdrawal of funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by University of MichiganThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05778695
Sponsor's protocol ID: HUM00213035
Status last verified: Feb 2025
First submitted: 21 Feb 2023
Last updated: 12 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones
ClinicalTrials.gov ID: NCT05778695
Acronym / sponsor ID: HUM00213035
Conditions: Parkinson Disease, Lewy Body Dementia, Parkinson Disease Dementia
Keywords: ketone ester, ketosis, functional neuroimaging
Study type: Interventional
Recruitment status: TerminatedReason stopped: Withdrawal of funding
Enrolment: 16 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Farmer Family Foundation
Study start: 9 Mar 2023 (actual)
Primary completion: 4 Oct 2023 (actual)
Study completion: 4 Oct 2023 (actual)
First posted: 21 Mar 2023 (actual)
Results: Posted 12 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Parkinson Disease	Experimental	Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-HydroxybutyrateParticipants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary.
Parkinson Disease Dementia/Lewy Body Dementia	Experimental	Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-HydroxybutyrateParticipants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary.
Healthy Controls	Experimental	Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-HydroxybutyrateParticipants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy control volunteers over 45 years of age
People with Parkinson Disease over 45 years of age
People with Parkinson's Disease Dementia or Lewy Body Dementia over 45 years of age

Key exclusion criteria (9 listed)

Participants with contra-indications to MR imaging, including pacemakers or claustrophobia;
Evidence of large vessel stroke or mass lesion on MRI
Regular use of anti-cholinergic, benzodiazepines, high dose (>100mg QD) of quetiapine, or neuroleptic drugs
History of significant GI disease
Significant metabolic or uncontrolled medical comorbidity

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 (R)-3-Hydroxybutyl (R)-3-HydroxybutyrateAlso: KetoneAidKetone ester (KE) dietary supplement (KetoneAid)	Dietary supplement	Healthy Controls, Parkinson Disease, Parkinson Disease Dementia/Lewy Body Dementia

Primary outcome

Glucose Metabolism
Time frame: Pre and post approximately 30 days of intervention
Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the ketone ester in patients with PD, Parkinson's disease dementia/Lewy body dementia, and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL within 2 hours of eating meals.
Clinical Dementia Rating Scale Score
Time frame: Pre and post approximately 30 days of intervention
The clinical dementia rating scale is a measure of functional and cognitive performance relevant to dementia. It is scored from 0 (normal) to 3 (severe dementia). The clinical dementia rating scale will be assessed in patients with Parkinson's disease, Parkinson's disease dementia/Lewy body dementia, and healthy controls before and after open-label treatment with the ketone ester.

Results and safety

Results posted to the registry on 12 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parkinson Disease	4	4
Parkinson Disease Dementia/Lewy Body Dementia	10	10
Healthy Controls	2	2

Primary outcome: Glucose Metabolism

Time frame: Pre and post approximately 30 days of intervention. Mean (Standard Deviation). Unit: milligrams per deciliter (mg/dL)

Measure	Parkinson Disease n = 4	Parkinson Disease Dementia/Lewy Body Dementia n = 7	Healthy Controls n = 2
Pre-intervention	133.0 (20.30)	134.86 (24.30)	179.50 (19.09)
Post-intervention	128.25 (18.26)	132.86 (33.42)	170.50 (21.92)

Parkinson Disease: Median Difference (Net): -14, p = 0.875, Wilcoxon (Mann-Whitney)
Parkinson Disease Dementia/Lewy Body Dementia: Mean Difference (Net): -2 (95% CI -16.026 to 12.026), p = 0.739, t-test, 2 sided

Population analysed: 13 of the 16 participants completed continuous glucose monitoring. The remaining 3 participants did not complete continuous glucose monitoring due to device availability and ability to understand instructions. Healthy control sample size (n=2) was not sufficient to perform statistical analysis for that group.

Primary outcome: Clinical Dementia Rating Scale Score

Time frame: Pre and post approximately 30 days of intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Parkinson Disease n = 4	Parkinson Disease Dementia/Lewy Body Dimentia n = 10	Healthy Controls n = 2
Pre-intervention	0.5 (0.41)	1.0 (0.85)	0 (0)
Post-intervention	0.5 (0.41)	1.15 (0.88)	0.25 (0.35)

Parkinson Disease Dementia/Lewy Body Dimentia: Median Difference (Net): 0, p = 0.37, Wilcoxon (Mann-Whitney)

Population analysed: All participants completed CDR before and after intervention. There was no change in CDR scores in the Parkinson's disease group, and the Healthy Control group had insufficient sample size (n = 2) to perform any statistical analysis.

Adverse events

Time frame: For all subjects, data was collected during the 30 +/- 7 days of tributyrin intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parkinson Disease	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Parkinson Disease Dementia/Lewy Body Dementia	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Healthy Controls	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Nicolaas Bohnen, MD principal investigator

University of Michigan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate in people with Parkinson Disease and Lewy Body Dementia, run by University of Michigan at 2 sites 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Glucose Metabolism (time frame: Pre and post approximately 30 days of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05778695.

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 12 Feb 2025.