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临床试验/NCT04389983
NCT04389983已完成不适用

Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil

University of Alberta1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Maximum plasma concentration (Cmax)

研究概览

简要总结

Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil

详细描述

Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil in three study populations: <65 year healthy, 65 and older healthy, and Alzheimer's disease.

Each subject attends for 4 study days, receiving incrementally larger MCT doses at each visit for 0g, to 14g, to 28g to 42g.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •adult, healthy or with AD

排除标准

  • •unable to attend all study days
  • •coconut allergy

研究组 & 干预措施

Healthy, under 65 years

Active Comparator

Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter (All MCT doses administered as a single dose at time 0)

干预措施: Medium Chain Triglyceride oil (Dietary Supplement)

Healthy, over 65 years

Active Comparator

Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter.

(All MCT doses administered as a single dose at time 0)

干预措施: Medium Chain Triglyceride oil (Dietary Supplement)

Alzheimer's Disease subjects

Active Comparator

Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter.

(All MCT doses administered as a single dose at time 0)

干预措施: Medium Chain Triglyceride oil (Dietary Supplement)

结局指标

主要结局

Maximum plasma concentration (Cmax)

时间窗: 3 months

Calculation of Cmax to varying doses in each subject and in different study arms.

Area under the curve (AUC)

时间窗: 3 months

Calculation of AUC to varying doses in each subject and in different study arms.

Time to maximum plasma concentration (tmax)

时间窗: 3 months

Calculation of tmax to varying doses in each subject and in different study arms.

次要结局

  • Body fat(3 months)
  • weight(3months)
  • height(3 months)
  • BMI(3months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Juby

PI

University of Alberta

研究点 (1)

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