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

NCT ID: NCT05446168

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-09-26

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parkinson's Disease Tributyrin Intervention

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

Group Type: EXPERIMENTAL

tributyrin

Intervention Type: 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

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

Group Type: EXPERIMENTAL

tributyrin

Intervention Type: DRUG

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

Interventions

tributyrin

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nicolaas Bohnen, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Nicolaas Bohnen, MD, PhD

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicolaas I Bohnen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00211320

Identifier Type: -

Identifier Source: org_study_id