Effect of a Ketogenic Supplement on Brain Energy Metabolism Measured by Neuroimaging in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in global ketone (11C-AcAc) uptake in grey matter
研究概览
简要总结
A six month, placebo-controlled, parallel group project in which MCI participants will receive 30 g/day of a custom-made MCT-based ketogenic supplement or a matching placebo. Uptake of both the brain's fuels - ketones (as 11C-AcAc) and glucose (as FDG) - both before and after the intervention will be assessed by PET (position emission tomography) ; imaging and ketone pharmacokinetic as primary objective as well as fMRI, diffusion MRI and cognition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjective memory complaint
- •Montreal Cognitive Assessment (MoCA) score of 18-26/30 or a Mini-mental state exam (MMSE) score of 24-27/30
- •autonomy for activity of daily living
- •absence of depression
排除标准
- •diagnosis of a major cognitive disorder
- •diseases or psychiatric disorders that could interfere with participation
- •uncontrolled diabetes (fasting plasma glucose >7 mM or glycated hemoglobin >6.5%)
- •major depression or history of alcohol or substance abuse within the past 2 years,
- •already supplementing with coconut oil or MCT
- •vitamin B12 deficiency
- •uncontrolled hypertension, dyslipidemia, or thyroid disease,
- •visual or hearing impairment impeding comprehension
- •participation in another intervention trial
- •inability to lie down without moving for 60 min (for the brain imaging)
- •presence of implanted metal objects or devices contraindicated for MRI (phase 1)
结局指标
主要结局
Change in global ketone (11C-AcAc) uptake in grey matter
时间窗: Baseline and 6 months of intervention
The change in brain ketone uptake will be quantified by PET and expressed as cerebral metabolic rate of AcAc (CMR-A)
Change in plasma ketone
时间窗: Baseline and 6 months of intervention
The change in plasma ketone will be measure to obtain a ketone chronic response
次要结局
- Blood metabolite profile triglycerides(Baseline and 6 months of intervention)
- Blood metabolite profile Glucose(Baseline and 6 months of intervention)
- Derived cerebral metabolic rate of total ketones(Baseline and 6 months of intervention)
- Pharmacokinetic ketone response (phase 2)(Baseline and 6 months of intervention)
- Change in regional CMR-A(Baseline and 6 months of intervention)
- Change in cognitive status- language domain(Baseline and 6 months of intervention)
- Change in global brain FDG uptake in grey matter (CMR-G)(Baseline and 6 months of intervention)
- regional brain volumes by vMRI(Baseline and 6 months of intervention)
- Change in cognitive status - episodic memory(Baseline and 6 months of intervention)
- Change in cognitive status - executive function(Baseline and 6 months of intervention)
- Change in cognitive status - processing speed(Baseline and 6 months of intervention)
- Blood metabolite profile cholesterol(Baseline and 6 months of intervention)