Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil

Not Applicable

Completed

• Conditions: Pharmacokinetics
• Interventions: Dietary Supplement: Medium Chain Triglyceride oil

• Registration Number: NCT04389983
• Lead Sponsor: University of Alberta

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-05-02
• Primary Completion: 2019-05-24
• Study Completion: 2020-04-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-15
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• adult, healthy or with AD

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy, over 65 years	Medium Chain Triglyceride oil	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)
Healthy, under 65 years	Medium Chain Triglyceride oil	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)
Alzheimer's Disease subjects	Medium Chain Triglyceride oil	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)

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	3 months	Calculation of Cmax to varying doses in each subject and in different study arms.
Area under the curve (AUC)	3 months	Calculation of AUC to varying doses in each subject and in different study arms.
Time to maximum plasma concentration (tmax)	3 months	Calculation of tmax to varying doses in each subject and in different study arms.

Secondary Outcome Measures

Name	Time	Method
weight	3months	measured in kg
Body fat	3 months	% measured by bioimpedence scale
height	3 months	measured in cm
BMI	3months	Calculated BMI (ht/m2)

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada