Effect of MCT Emulsification on Ketogenesis in Human Adults

January 28, 2019 updated by: Université de Sherbrooke

Effect of Medium-chain Triglycerides Emulsification on Ketogenesis and Adverse Effects in Human Adults

Lower brain glucose uptake is present before the onset of cognitive deterioration and may increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized and are ketogenic. Large doses of MCT oil are linked to gastro-intestinal side effects due to incomplete absorption so the investigators examined whether homogenisation into a skim milk matrix (MCT-H) would both improve ketogenesis and reduce side-effects compared to MCT taken without homogenisation into a matrix (bulk MCT [MCT-B]).

Hypotheses: (i) MCT-H will be better absorbed compared to MCT-B, so MCT-H will result in higher ketonemia and lower side effects in healthy adults. (ii) The effects of MCT-B and MCT-H on ketogenesis will be dose-dependent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 18 years or more

Exclusion Criteria:

  • smoker
  • pregnancy or breastfeeding
  • diabetes or insulin resistance
  • uncontrolled thyroid disease, hepatic or renal disease
  • uncontrolled high blood pressure
  • medical treatment influencing lipid or glucide metabolism
  • ongoing or past severe drug or alcohol abuse
  • dementia or psychiatric difficulties or depression
  • chronic immune condition or inflammation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy participant
Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)
Dietary supplement: MCT oil 10g
10 g of pure MCT oil mixed with skim milk in a standardized breakfast
Dietary supplement: MCT homogenate 10g
10g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast
Dietary supplement: Control
vehicule (skim milk) with a standardized breakfast
Dietary supplement: MCT oil 20g
20g of pure MCT oil mixed with skim milk in a standardized breakfast
Dietary supplement: MCT homogenate 20g
20g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast
Dietary supplement: MCT oil 30g
30g of 100% pure MCT oil mixed with skim milk in a standardized breakfast
Dietary supplement: MCT homogenate 30g
30g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Ketone Concentration
Time Frame: Average of every 30 minutes for 4 hours following intake of supplement
Average of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements
Average of every 30 minutes for 4 hours following intake of supplement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose Concentration
Time Frame: Average of every 30 minutes for 4 hours following intake of supplement
average of glucose measured every 30 minutes during the four hour of each metabolic day
Average of every 30 minutes for 4 hours following intake of supplement
Plasma Free Fatty Acids Concentration
Time Frame: average of 4 hours following intake of supplement
average of free fatty acids measured every 30 minutes during the four hour fo each metabolic day
average of 4 hours following intake of supplement
Plasma Insuline Concentration
Time Frame: average of 4 hours following intake of supplement
Average of insulin measured evey 30 minutes during the 4 hours of each metabolic day
average of 4 hours following intake of supplement
Number of Participants With Side Effects for Each Visit
Time Frame: During the 4 hours following intake of supplement
If participant had any side effect (mild or moderate) at least one time during the day.
During the 4 hours following intake of supplement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Stephen C Cunnane, PhD, Universite de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-391

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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