Tributyrin for Parkinson's Disease

(BUTTER Trial)

Overseen By Alexis Griggs, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nicolaas Bohnen, MD, PhD

Must not be taking: Anticholinergics, Benzodiazepines, Neuroleptics

Disqualifiers: Stroke, GI disease, Diabetes, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement called tributyrin can help people with Parkinson's disease. Researchers aim to determine if this short-chain fatty acid might improve symptoms or brain health. The trial includes two groups: one with healthy individuals and another with people who have Parkinson's. Participants must be over 45 and either have Parkinson's or be healthy without major health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial excludes people who regularly use anti-cholinergic, benzodiazepines, or neuroleptic drugs, so you may need to stop these medications to participate. The protocol does not specify about other medications.

Is there any evidence suggesting that tributyrin is likely to be safe for humans?

Research has shown that tributyrin is generally safe to use. Past studies found it caused slight eye irritation but reported no serious long-term health effects. Tributyrin contains no dangerous materials with specific exposure limits, suggesting it is unlikely to cause significant harm under normal conditions. However, like any substance, it should be handled carefully to avoid minor irritations. Following safety guidelines, such as washing hands after use, reduces any risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Unlike the standard treatments for Parkinson's disease that mainly aim to manage symptoms through dopamine replacement or modulation, tributyrin offers a fresh approach by targeting brain metabolism. Tributyrin is a small chain fatty acid that can potentially influence brain health by altering metabolic pathways, which is quite different from traditional medications like levodopa or dopamine agonists. Researchers are excited about tributyrin because it may offer neuroprotective benefits, potentially slowing disease progression rather than just addressing symptoms. This novel mechanism of action could represent a significant advancement in how we approach Parkinson's treatment.

What evidence suggests that tributyrin might be an effective treatment for Parkinson's disease?

This trial will evaluate the effects of tributyrin in two different participant groups. Research suggests that tributyrin might help alleviate symptoms of Parkinson's disease. As a type of fatty acid, tributyrin can boost brain health by raising levels of butyrate, which may protect brain cells. Studies have shown that butyrate can improve sleep and might lessen some symptoms of the disease. Additionally, tributyrin can help balance gut bacteria, which is important because gut health is connected to brain health. While these findings are promising, further research is needed to confirm its effectiveness in treating Parkinson's disease. ^{6 7 8 9 10}

Who Is on the Research Team?

Nicolaas I Bohnen, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Inclusion Criteria

Healthy control volunteers over 45 years of age

People with Parkinson Disease over 45 years of age

Exclusion Criteria

Evidence of large vessel stroke or mass lesion on MRI

Poorly controlled diabetes

Dementia requiring informed assent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 500mg TID tributyrin supplement for 30 days +/- 7 days

4-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tributyrin

How Is the Trial Designed?

Group I: Parkinson's Disease Tributyrin Intervention Experimental Treatment 1 Intervention

Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.

Group II: Healthy Control Tributyrin Intervention Experimental Treatment 1 Intervention

Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.

Who Is Running the Clinical Trial?

Nicolaas Bohnen, MD, PhD

Lead Sponsor

Trials

2

Recruited

50+

Citations

1.

jnm.snmjournals.org

jnm.snmjournals.org/content/65/supplement_2/242483

Tributyrin Supplementation Increases Brain Butyrate ...

30-day tributyrin supplementation was associated with widespread decreases in 11C-butyrate uptake from pre to post-treatment scans.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06501898

Tributyrin: Time Course & Efficacy to Improve Health & ...

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

3.

nature.com

nature.com/articles/s41531-025-01029-5

Butyrate improves abnormal sleep architecture in a ...

Both direct and indirect supplementation with butyrate have shown efficacy in mitigating the pathology of PD. Based on these evidences, the ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10389721/

Tributyrin alleviates gut microbiota dysbiosis to repair ...

Tributyrin alleviates gut microbiota dysbiosis to repair intestinal damage in antibiotic-treated mice.

5.

ichgcp.net

ichgcp.net/clinical-trials-registry/NCT07154511

Phase 2 Trial of Tributyrin in People With Parkinson's Disease ...

The goal of this clinical trial is to learn if taking a tributyrin supplement works to improve memory and thinking and walking and balance ...

6.

fishersci.com

fishersci.com/store/msds?partNumber=AC150881000&productDescription=TRIBUTYRIN+98%25+100ML&vendorId=VN00032119&countryCode=US&language=en

SAFETY DATA SHEET

This product does not contain any hazardous materials with occupational exposure limitsestablished by the region specific regulatory bodies. 9.

7.

carlroth.com

carlroth.com/downloads/sdb/en/4/SDB_4813_AU_EN.pdf

Safety Data Sheet: Glycerol tributyrate

Combustible. Hazardous combustion products. In case of fire may be liberated: Carbon monoxide (CO), Carbon dioxide (CO₂). 5.3.

8.

sigmaaldrich.com

sigmaaldrich.com/sds/sial/91010?srsltid=AfmBOoqXa5dGi2iIkszceZlzrJQ3ju3_SBdkfBqMnCndx6B8MDYPnpRS

SAFETY DATA SHEET

Specific hazards during fire fighting. : Vapours are heavier than air and may spread along floors. Forms explosive mixtures with air on intense ...

9.

tmmedia.in

tmmedia.in/wp-content/uploads/MSDS/MSDS-851.pdf

GLYCEROL TRIBUTYRATE (Tributyrin)

Potential Acute Health Effects: Slightly hazardous in case of eye contact (irritant). Potential Chronic Health Effects: Carcinogenic effects: Not available.

10.

synerzine.com

synerzine.com/docs/sds/W0202%20SDS%20(US-English).pdf

Glyceryl tributyrate

Hygiene measures. : Do not eat, drink or smoke when using this product. Always wash hands after handling the product. 7.2. Conditions for safe ...