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

Nicolaas Bohnen, MD, PhD

Status and phase: Terminated; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: tributyrin

Study type: Interventional

Funder types: Other

Identifiers

NCT05446168

HUM00211320

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Parkinson's Disease Tributyrin Intervention

Experimental group

Description:

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

Treatment:

Drug: tributyrin

Healthy Control Tributyrin Intervention

Experimental group

Description:

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

Treatment:

Drug: tributyrin