Proof of Concepts: Can a Supplement Ketogenic Based MCT Oil Increases Cerebral Capture Ketones in People With Alzheimer's Disease?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quantification of brain glucose uptake
研究概览
简要总结
Evaluate and compare the changes in brain ketone and glucose uptake after taking two different MCT oil emulsions (60-40 oil or C8 oil) for one month, in a group of people with Alzheimer's disease and a control group.
详细描述
Based on a PET/MRI protocol, the aim of this study is to evaluate and compare the response to the dietary supplementation of two different MCT oils (60% C10 + 40% C8 or 100 % C8) in two groups, patients with Alzheimer's disease and healthy elderly people (N=10/group). After a baseline evaluation, participant will test one of the supplements during two successive periods of one month; each period of time ending with 18F-FDG and 11C-acetoacetate PET scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health for Control group
- •Diagnosis of Alzheimer's disease (NINCDS-ADRDA criteria) for AD group
排除标准
- •Depression
- •Medical or psychiatric conditions that could interfere with study participation
- •Fasting plasma glucose ≥7.0 mM (diabetes or prediabetes)
- •Already on MCT supplementation
- •Clinically-significant gastrointestinal disease/conditions
- •Clinically-significant liver disease/dysfunction
- •Clinically-significant renal disease/dysfunction
- •Clinically-significant cardiac disease/conditions
- •Hypertension
- •Uncontrolled dyslipidaemia
- •Vitamin B12 deficiency
- •Structured physical activity (more than 3 times/week)
研究组 & 干预措施
Alzheimer's disease
Patients with mild Alzheimer's disease.
1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
干预措施: 1-month of 60-40 MCT oil (Dietary Supplement)
Alzheimer's disease
Patients with mild Alzheimer's disease.
1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
干预措施: 1-month of C8 MCT oil (Dietary Supplement)
Controls
Healthy elderly people
1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
干预措施: 1-month of 60-40 MCT oil (Dietary Supplement)
Controls
Healthy elderly people
1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
干预措施: 1-month of C8 MCT oil (Dietary Supplement)
结局指标
主要结局
Quantification of brain glucose uptake
时间窗: 1-month
Brain glucose uptake (umol/100g/min) using 18-FDG PET scan
Quantification of brain acetoacetate uptake
时间窗: 1-month
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan
次要结局
未报告次要终点