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

Phase 1TerminatedNCT05446168

Nicolaas Bohnen, MD, PhD18 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

tributyrinDRUG

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

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Pre and Post approximately 30 days of intervention

Data from ClinicalTrials.gov

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