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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tributyrin
Sponsored by
Nicolaas Bohnen, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring short chain fatty acid, butyrate, tributyrin, functional neuroimaging

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility LaboratoryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tributyrin Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

FDG glucose PET brain
Brain PET glucose radiotracer binding
MoCa
Montreal Cognitive Assessment cognitive rating scale
butyrate PET brain
butyrate PET radiotracer binding

Full Information

First Posted
July 1, 2022
Last Updated
September 13, 2022
Sponsor
Nicolaas Bohnen, MD, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT05446168
Brief Title
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
Acronym
BUTTER
Official Title
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicolaas Bohnen, MD, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
short chain fatty acid, butyrate, tributyrin, functional neuroimaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tributyrin Intervention
Arm Type
Experimental
Arm Description
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Intervention Type
Drug
Intervention Name(s)
tributyrin
Intervention Description
Post-biotic short chain fatty acid dietary supplement
Primary Outcome Measure Information:
Title
glucose metabolism
Description
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
Time Frame
after approximately 30 days of intervention
Secondary Outcome Measure Information:
Title
FDG glucose PET brain
Description
Brain PET glucose radiotracer binding
Time Frame
after approximately 30 days of intervention
Title
MoCa
Description
Montreal Cognitive Assessment cognitive rating scale
Time Frame
after approximately 30 days of intervention
Title
butyrate PET brain
Description
butyrate PET radiotracer binding
Time Frame
after approximately 30 days of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Griggs, BA
Phone
734-998-8400
Email
gralexis@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Bohnen, BSc
Phone
734-998-8400
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaas I Bohnen, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Griggs, BA
Phone
734-998-8420
Email
gralexis@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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