Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Dietary supplement: Medium Chain Triglyceride 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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2P4
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult, healthy or with AD

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy, under 65 years; 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)	Dietary supplement: Medium Chain Triglyceride oil; Bulletproof Braine Octane MCT oil
Active Comparator: Healthy, over 65 years; 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)	Dietary supplement: Medium Chain Triglyceride oil; Bulletproof Braine Octane MCT oil
Active Comparator: Alzheimer's Disease subjects; 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)	Dietary supplement: Medium Chain Triglyceride oil; Bulletproof Braine Octane MCT oil

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	measured in kg	3months
height	measured in cm	3 months
BMI	Calculated BMI (ht/m2)	3months
Body fat	% measured by bioimpedence scale	3 months

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Angela Juby, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Actual): May 24, 2019
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: MCT oil
• Other Study ID Numbers: 00087958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No