Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Whole Brain Butyrate PET Radiotracer Binding
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy control volunteers over 45 years of age
- •People with Parkinson Disease over 45 years of age
排除标准
- •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
研究组 & 干预措施
Parkinson's Disease Tributyrin Intervention
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
干预措施: tributyrin (Drug)
Healthy Control Tributyrin Intervention
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
干预措施: tributyrin (Drug)
结局指标
主要结局
Whole Brain Butyrate PET Radiotracer Binding
时间窗: Pre and Post approximately 30 days of intervention
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.
Glucose Metabolism
时间窗: Pre and Post approximately 30 days of intervention
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.
次要结局
未报告次要终点
研究者
Nicolaas Bohnen, MD, PhD
Professor of Radiology
University of Michigan