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

Parkinson Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05446168
• Other study ID #: HUM00211320
• Status: Terminated
• Phase: Phase 1
• Start date: July 1, 2022
• Est. completion date: September 26, 2023

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaas Bohnen, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	FDG glucose PET brain	Brain PET glucose radiotracer binding	after approximately 30 days of intervention
Secondary	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
Secondary	butyrate PET brain	butyrate PET radiotracer binding	after approximately 30 days of intervention