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NCT04389983 Clinical Trial

Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil

Pharmacokinetics Clinical Trial

Official title:
Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04389983
Other study ID # 00087958
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2019
Est. completion date April 15, 2020

Study information
Verified date May 2020
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date April 15, 2020
Est. primary completion date May 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- adult, healthy or with AD

Exclusion Criteria:

- unable to attend all study days

- coconut allergy

- Diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Medium Chain Triglyceride oil
Bulletproof Braine Octane MCT oil

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum plasma concentration (Cmax) Calculation of Cmax to varying doses in each subject and in different study arms. 3 months
Primary Time to maximum plasma concentration (tmax) Calculation of tmax to varying doses in each subject and in different study arms. 3 months
Primary Area under the curve (AUC) Calculation of AUC to varying doses in each subject and in different study arms. 3 months
Secondary weight measured in kg 3months
Secondary height measured in cm 3 months
Secondary BMI Calculated BMI (ht/m2) 3months
Secondary Body fat % measured by bioimpedence scale 3 months
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