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SCFA Prodrug
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation (BUTTER Trial)
Phase 1
Waitlist Available
Led By Nicolaas I Bohnen, MD, PhD
Research Sponsored by Nicolaas Bohnen, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after approximately 30 days of intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing tributyrin, a substance that turns into a helpful fatty acid in the body. It aims to see if it can improve brain function and metabolism in people with Parkinson's disease and normal older adults. If successful, it could lead to further studies on using this fatty acid for health benefits. Sodium butyrate, a similar compound to tributyrin, has shown potential in improving motor and cognitive deficits in Parkinson's disease models.
Eligible Conditions
- Parkinson's Disease
- Dementia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after approximately 30 days of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after approximately 30 days of intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
glucose metabolism
Secondary study objectives
FDG glucose PET brain
Montreal Cognitive Assessment cognitive rating scale (MoCa)
Brain
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Parkinson's Disease Tributyrin InterventionExperimental Treatment1 Intervention
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Group II: Healthy Control Tributyrin InterventionExperimental Treatment1 Intervention
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tributyrin
Not yet FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Nicolaas Bohnen, MD, PhDLead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
Nicolaas I Bohnen, MD, PhDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You regularly take medications for anxiety, sleep, or mental health that affect your brain function.You are pregnant or currently breastfeeding.You have a history of serious gastrointestinal (GI) problems.You have thoughts of harming yourself.You have severe health conditions that are not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Control Tributyrin Intervention
- Group 2: Parkinson's Disease Tributyrin Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT05446168 — Phase 1