Parkinson DiseasePhase 1BUTTERNCT05446168

Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation

A Phase 1 study testing tributyrin in people with Parkinson Disease, run by Nicolaas Bohnen, MD, PhD at 1 site 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 the short-chain fatty acid (SCFA) prodrug tributyrin as a potential therapy for persons with Parkinson disease 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
What is being tested?: tributyrin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2022to 26 Sep 2023
Phase: Phase 1
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

Who cannot join

Subjects 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 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
Dementia requiring informed assent
Suicidal ideation

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, 48106

Other trials in United States

About this study

Small exploratory open-label pilot study to assess the short-chain fatty acid (SCFA) prodrug tributyrin as a potential therapy for persons with Parkinson disease

Read the detailed description

The overarching goal of this small exploratory open-label pilot study is to explore metabolic (glucose metabolism, butyrate) and cognition (MoCa) before and after open-label treatment with the short-chain fatty acid (SCFA) prodrug tributyrin in a small pilot study in PD and normal control older adults. Positive findings in this small exploratory pilot trial may support target engagement study of SCFA supplementation in normal adults and PD.

Conditions: Parkinson Disease
Being tested: tributyrin
Keywords: short chain fatty acid, butyrate, tributyrin, functional neuroimaging
Medical subject headings: Parkinson Disease

What participants receive

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

tributyrinDrug
Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.

Study groups in NCT05446168
Study group	Role	What they receive
Parkinson's Disease Tributyrin Intervention	Experimental	Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days. Receives: Drug: tributyrin
Healthy Control Tributyrin Intervention	Experimental	Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days. Receives: Drug: tributyrin

What is being measured

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

Whole Brain Butyrate PET Radiotracer Binding
Whole-brain butyrate distribution volume ratios (DVRs) were computed relative to a cerebral white matter reference region pre and post approximately 30 days of open-label treatment with tributyrin. Lower radiotracer binding is interpreted to reflect higher levels of (non-tracer) butyrate in the brain, whereas higher radiotracer binding reflects higher butyrate receptor binding site availability, indicating lower levels of non-tracer butyrate in the brain.
Measured: Pre and Post approximately 30 days of intervention
Glucose Metabolism
Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the SCFA prodrug tributyrin in patients with PD 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 withing 2 hours of eating meals.
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.

1 Jul 202226 Sep 2023

First posted6 Jul 2022
Study start1 Jul 2022
Primary completion26 Sep 2023
Study completion26 Sep 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.
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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05446168
Sponsor's protocol ID: HUM00211320
Acronym: BUTTER
Status last verified: Dec 2024
First submitted: 1 Jul 2022
Last updated: 23 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
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 23 Jan 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: Tributyrin Supplementation
ClinicalTrials.gov ID: NCT05446168
Acronym / sponsor ID: BUTTER / HUM00211320
Conditions: Parkinson Disease
Keywords: short chain fatty acid, butyrate, tributyrin, functional neuroimaging
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Withdrawal of funding
Enrolment: 18 participants (actual)
Lead sponsor: Nicolaas Bohnen, MD, PhDUniversity, hospital or other
Study start: 1 Jul 2022 (actual)
Primary completion: 26 Sep 2023 (actual)
Study completion: 26 Sep 2023 (actual)
First posted: 6 Jul 2022 (actual)
Results: Posted 23 Jan 2025

Clinical summary

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

Small exploratory open-label pilot study to assess the short-chain fatty acid (SCFA) prodrug tributyrin as a potential therapy for persons with Parkinson disease

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Parkinson's Disease Tributyrin Intervention	Experimental	Drug: tributyrinParticipants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Healthy Control Tributyrin Intervention	Experimental	Drug: tributyrinParticipants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy control volunteers over 45 years of age
People with Parkinson Disease over 45 years of age

Key exclusion criteria (9 listed)

Subjects 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 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
tributyrinPost-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.	Drug	Healthy Control Tributyrin Intervention, Parkinson's Disease Tributyrin Intervention

Primary outcome

Whole Brain Butyrate PET Radiotracer Binding
Time frame: Pre and Post approximately 30 days of intervention
Whole-brain butyrate distribution volume ratios (DVRs) were computed relative to a cerebral white matter reference region pre and post approximately 30 days of open-label treatment with tributyrin. Lower radiotracer binding is interpreted to reflect higher levels of (non-tracer) butyrate in the brain, whereas higher radiotracer binding reflects higher butyrate receptor binding site availability, indicating lower levels of non-tracer butyrate in the brain.
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 SCFA prodrug tributyrin in patients with PD 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 withing 2 hours of eating meals.

Results and safety

Results posted to the registry on 23 Jan 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's Disease Tributyrin Intervention	14	14
Healthy Control Tributyrin Intervention	3	2

Primary outcome: Whole Brain Butyrate PET Radiotracer Binding

Time frame: Pre and Post approximately 30 days of intervention. Mean (Standard Deviation). Unit: Parametric DVR

Measure	Parkinson's Disease Tributyrin Intervention n = 8	Healthy Control Tributyrin Intervention n = 2
Pre-intervention	1.81 (0.10)	1.79 (0.02)
Post-intervention	1.73 (0.10)	1.74 (0.01)

Parkinson's Disease Tributyrin Intervention: Mean Difference (Net): -0.08 (95% CI -0.12 to -0.03), p = 0.005, t-test, 2 sided

Population analysed: Brain imaging was not strictly required for participation in the remaining components of the study. Not all participants underwent PET imaging. Healthy control sample size (n=2) was not sufficient to perform statistical analysis for that group.

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's Disease Tributyrin Intervention n = 12	Healthy Control Tributyrin Intervention n = 2
Pre-Intervention	135.00 (49.39)	104.50 (3.54)
Post-Intervention	139.33 (53.31)	125.00 (4.24)

Parkinson's Disease Tributyrin Intervention: Mean Difference (Net): 4.33 (95% CI -3.81 to 12.47), p = 0.27, t-test, 2 sided

Population analysed: 2 Parkinson's disease participants did not complete continuous glucose monitoring due to scheduling conflicts, thus only 14/16 participants were included in this analysis. Healthy control sample size (n=2) was not sufficient to perform statistical analysis for that group.

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's Disease Tributyrin Intervention	0 of 14 (0%)	13 of 14 (92.9%)	0 of 14
Healthy Control Tributyrin Intervention	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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 I Bohnen, MD, PhD principal investigator

University of Michigan

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tributyrin in people with Parkinson Disease, run by Nicolaas Bohnen, MD, PhD 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 2 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 23 Jan 2025. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 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?

Whole Brain Butyrate PET Radiotracer Binding (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 NCT05446168.

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 23 Jan 2025.