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

Phase 1

Terminated

• Conditions: Parkinson Disease
• Interventions: Drug: tributyrin

• Registration Number: NCT05446168
• Lead Sponsor: Nicolaas Bohnen, MD, PhD

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

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-06
• Primary Completion: 2023-09-26
• Study Completion: 2023-09-26
• Results First Submitted: 2024-09-05
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Results First Posted: 2025-01-23
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson's Disease Tributyrin Intervention	tributyrin	Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Healthy Control Tributyrin Intervention	tributyrin	Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.

Primary Outcome Measures

Name	Time	Method
Whole Brain Butyrate PET Radiotracer Binding	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	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.

Trial Locations

Locations (1)

University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory; 🇺🇸 Ann Arbor, Michigan, United States