NCT04389983

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

22 days

First QC Date

May 7, 2020

Last Update Submit

May 11, 2020

Conditions

Pharmacokinetics

Keywords

MCT oil

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • weight

    3months

  • height

    3 months

  • BMI

    3months

  • Body fat

    3 months

Study Arms (3)

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)

Dietary Supplement: Medium Chain Triglyceride oil

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)

Dietary Supplement: Medium Chain Triglyceride oil

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)

Dietary Supplement: Medium Chain Triglyceride oil

Interventions

Medium Chain Triglyceride oilDIETARY_SUPPLEMENT

Bulletproof Braine Octane MCT oil

Alzheimer's Disease subjectsHealthy, over 65 yearsHealthy, under 65 years

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult, healthy or with AD

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2P4, Canada

Location

Study Officials

  • Angela Juby

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 15, 2020

Study Start

May 2, 2019

Primary Completion

May 24, 2019

Study Completion

April 15, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)