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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: tributyrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson's Disease Tributyrin Intervention<br>Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days. | Drug: tributyrin<br>* Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.<br>|
| Experimental: Healthy Control Tributyrin Intervention<br>Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days. | Drug: tributyrin<br>* Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose metabolism | continuous glucose meter 24 hr average glucose readings before/after open-label treatment with the SCFA prodrug tributyrin in patients with PD and normal controls | after approximately 30 days of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FDG glucose PET brain | Brain PET glucose radiotracer binding | after approximately 30 days of intervention | 
| Montreal Cognitive Assessment cognitive rating scale (MoCa) | Montreal Cognitive Assessment cognitive rating scale is a cognitive assessment with scores ranging from 0-30, with higher scores indicating better cognitive function. | after approximately 30 days of intervention | 
| butyrate PET brain | butyrate PET radiotracer binding | after approximately 30 days of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short chain fatty acid, butyrate, tributyrin, functional neuroimaging