Effect of MCT Emulsification on Ketogenesis in Human Adults

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: MCT oil 10g; Dietary Supplement: MCT homogenate 10g; Dietary Supplement: Control; Dietary Supplement: MCT oil 20g; Dietary Supplement: MCT homogenate 20g; Dietary Supplement: MCT oil 30g; Dietary Supplement: MCT homogenate 30g

• Registration Number: NCT02409927
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Status Verified: 2015-05
• Results First Submitted: 2017-08-29
• Results First Submitted QC: 2018-06-11
• Results First Posted: 2018-12-17
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy participant	Control	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)
Healthy participant	MCT homogenate 20g	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)
Healthy participant	MCT homogenate 30g	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)
Healthy participant	MCT oil 10g	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)
Healthy participant	MCT oil 20g	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)
Healthy participant	MCT homogenate 10g	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)
Healthy participant	MCT oil 30g	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)

Primary Outcome Measures

Name	Time	Method
Plasma Ketone Concentration	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

Secondary Outcome Measures

Name	Time	Method
Plasma Insuline Concentration	average of 4 hours following intake of supplement	Average of insulin measured evey 30 minutes during the 4 hours of each metabolic day
Number of Participants With Side Effects for Each Visit	During the 4 hours following intake of supplement	If participant had any side effect (mild or moderate) at least one time during the day.
Plasma Glucose Concentration	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
Plasma Free Fatty Acids Concentration	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