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

NCT05446168 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: HUM00211320
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parkinson Disease

Keywords

short chain fatty acid; butyrate; tributyrin; functional neuroimaging

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Pre and Post approximately 30 days of intervention

Study Arms (2)

Parkinson's Disease Tributyrin Intervention

EXPERIMENTAL

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

Drug: tributyrin

Healthy Control Tributyrin Intervention

EXPERIMENTAL

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

Drug: tributyrin

Interventions

tributyrin DRUG

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

Healthy Control Tributyrin Intervention; Parkinson's Disease Tributyrin Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Pregnancy or breast feeding
• Dementia requiring informed assent
• Suicidal ideation

Sponsors & Collaborators

• Nicolaas Bohnen, MD, PhD: lead

Study Sites (1)

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

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

tributyrin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Nicolaas Bohnen, MD, PhD
• Organization: University of Michigan

nbohnen@umich.edu

734-936-1168

Study Officials

• Nicolaas I Bohnen, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Study Start: July 1, 2022
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)