A Phase 1 interventional study of tributyrin in Parkinson Disease, sponsored by Nicolaas Bohnen, MD, PhD. Terminated at 1 site in United States. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Nicolaas Bohnen, MD, PhD · Phase 1, Interventional, and Treatment
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
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.
Exclusion Criteria:
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Drug: tributyrin
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Drug: tributyrin
Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Whole Brain Butyrate PET Radiotracer Binding
Whole-brain butyrate distribution volume ratios (DVRs) were computed relative to a cerebral white matter reference region pre and post approximately 30 days of open-label treatment with tributyrin. Lower radiotracer binding is interpreted to reflect higher levels of (non-tracer) butyrate in the brain, whereas higher radiotracer binding reflects higher butyrate receptor binding site availability, indicating lower levels of non-tracer butyrate in the brain.
Time frame: Pre and Post approximately 30 days of intervention
Glucose Metabolism
Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the SCFA prodrug tributyrin in patients with PD and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL withing 2 hours of eating meals.
Time frame: Pre and Post approximately 30 days of intervention
| Milestone | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention |
|---|---|---|
| Started | 14 | 3 |
| Completed | 14 | 2 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
Whole-brain butyrate distribution volume ratios (DVRs) were computed relative to a cerebral white matter reference region pre and post approximately 30 days of open-label treatment with tributyrin. Lower radiotracer binding is interpreted to reflect higher levels of (non-tracer) butyrate in the brain, whereas higher radiotracer binding reflects higher butyrate receptor binding site availability, indicating lower levels of non-tracer butyrate in the brain.
| Parametric DVR | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention |
|---|---|---|
| Pre-intervention | 1.81 ± 0.10 | 1.79 ± 0.02 |
| Post-intervention | 1.73 ± 0.10 | 1.74 ± 0.01 |
Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the SCFA prodrug tributyrin in patients with PD and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL withing 2 hours of eating meals.
| milligrams per deciliter (mg/dL) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention |
|---|---|---|
| Pre-Intervention | 135.00 ± 49.39 | 104.50 ± 3.54 |
| Post-Intervention | 139.33 ± 53.31 | 125.00 ± 4.24 |
Collected over For all subjects, data was collected during the 30 +/- 7 days of tributyrin intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parkinson's Disease Tributyrin Intervention | 0/14 (0%) | 0/14 (0%) | 13/14 (92.9%) |
| Healthy Control Tributyrin Intervention | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention |
|---|---|---|
| GI DiscomfortGastrointestinal disorders | 7/14 | 0/3 |
| Behavioral DisturbancePsychiatric disorders | 0/14 | 1/3 |
| HeadacheNervous system disorders | 0/14 | 1/3 |
| Respiratory InfectionInfections and infestations | 4/14 | 0/3 |
| Sleep DisruptionNervous system disorders | 3/14 | 0/3 |
| Shakiness/DyskinesiaNervous system disorders | 2/14 | 0/3 |
| Urinary Tract InfectionInfections and infestations | 2/14 | 0/3 |
| Toe InjuryInjury, poisoning and procedural complications | 1/14 | 0/3 |
| ClaustrophobiaPsychiatric disorders | 1/14 | 0/3 |
| Gait DisturbancesNervous system disorders | 1/14 | 0/3 |
| Age, Categorical(Participants) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 1 | 6 |
| >=65 years | 9 | 2 | 11 |
| Age, Continuous(years) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention | Total |
|---|---|---|---|
| Mean | 66.4 ± 5.7 | 67.3 ± 10.6 | 66.5 ± 6.4 |
| Sex: Female, Male(Participants) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 9 | 1 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 14 | 3 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 14 | 3 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention | Total |
|---|---|---|---|
| United States | 14 | 3 | 16 |
| Education(years) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention | Total |
|---|---|---|---|
| Mean | 17.9 ± 2.8 | 19.3 ± 3.5 | 18.1 ± 2.9 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III(units on a scale) | Parkinson's Disease Tributyrin Intervention | Healthy Control Tributyrin Intervention | Total |
|---|---|---|---|
| Mean | 46.9 ± 12.7 | 28.0 ± 20.5 | 43.6 ± 15.5 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Nicolaas Bohnen, MD, PhD