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Effect of MCT Emulsification on Ketogenesis in Human Adults

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02409927
Enrollment
10
Registered
2015-04-07
Start date
2013-07-31
Completion date
2014-09-30
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Medium-chain triglycerides, Metabolism, Ketones, Lipids, Emulsification

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.

Interventions

DIETARY_SUPPLEMENTMCT oil 10g

10 g of pure MCT oil mixed with skim milk in a standardized breakfast

DIETARY_SUPPLEMENTMCT homogenate 10g

10g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast

DIETARY_SUPPLEMENTControl

vehicule (skim milk) with a standardized breakfast

DIETARY_SUPPLEMENTMCT oil 20g

20g of pure MCT oil mixed with skim milk in a standardized breakfast

DIETARY_SUPPLEMENTMCT homogenate 20g

20g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast

DIETARY_SUPPLEMENTMCT oil 30g

30g of 100% pure MCT oil mixed with skim milk in a standardized breakfast

DIETARY_SUPPLEMENTMCT homogenate 30g

30g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Each participant underwent 7 metabolic day (1-day visit), each visit separate by a minimum of 3 day

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma Ketone ConcentrationAverage of every 30 minutes for 4 hours following intake of supplementAverage of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements

Secondary

MeasureTime frameDescription
Plasma Glucose ConcentrationAverage of every 30 minutes for 4 hours following intake of supplementaverage of glucose measured every 30 minutes during the four hour of each metabolic day
Plasma Free Fatty Acids Concentrationaverage of 4 hours following intake of supplementaverage of free fatty acids measured every 30 minutes during the four hour fo each metabolic day
Plasma Insuline Concentrationaverage of 4 hours following intake of supplementAverage of insulin measured evey 30 minutes during the 4 hours of each metabolic day
Number of Participants With Side Effects for Each VisitDuring the 4 hours following intake of supplementIf participant had any side effect (mild or moderate) at least one time during the day.

Participant flow

Participants by arm

ArmCount
Healthy
Participants involved in the project had seven metabolic study day to do : control day (no supplement), MCT oil 10,20 or 30 g, and MCT homogenate 10, 20 or 30 g. They were taking the supplement with a breakfast and there was blood sampling every 30 minutes.t
10
Total10

Baseline characteristics

CharacteristicHealthy
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
Age, Continuous31 years
STANDARD_DEVIATION 3
Region of Enrollment
Canada
10 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
4 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Plasma Ketone Concentration

Average of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements

Time frame: Average of every 30 minutes for 4 hours following intake of supplement

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantPlasma Ketone Concentrationcontrol136.97 µmol/LStandard Error 11.33
Healthy ParticipantPlasma Ketone Concentration10g MCT oil177.43 µmol/LStandard Error 14.711
Healthy ParticipantPlasma Ketone Concentration20 g MCT oil270.61 µmol/LStandard Error 27.477
Healthy ParticipantPlasma Ketone Concentration30 g MCT oil249.3 µmol/LStandard Error 17.474
Healthy ParticipantPlasma Ketone Concentration10g MCT homogenate262.92 µmol/LStandard Error 26.82
Healthy ParticipantPlasma Ketone Concentration20g MCT homogenate277.25 µmol/LStandard Error 30.006
Healthy ParticipantPlasma Ketone Concentration30 g MCT homogenate244.74 µmol/LStandard Error 65.83
Secondary

Number of Participants With Side Effects for Each Visit

If participant had any side effect (mild or moderate) at least one time during the day.

Time frame: During the 4 hours following intake of supplement

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Healthy ParticipantNumber of Participants With Side Effects for Each Visitcontrol0 Participants
Healthy ParticipantNumber of Participants With Side Effects for Each Visit10 g MCT oil1 Participants
Healthy ParticipantNumber of Participants With Side Effects for Each Visit20 g MCT oil4 Participants
Healthy ParticipantNumber of Participants With Side Effects for Each Visit30 g MCT oil5 Participants
Healthy ParticipantNumber of Participants With Side Effects for Each Visit10 g MCT homogenate2 Participants
Healthy ParticipantNumber of Participants With Side Effects for Each Visit20g MCT homogenate4 Participants
Healthy ParticipantNumber of Participants With Side Effects for Each Visit30g MCT homogenate5 Participants
Secondary

Plasma Free Fatty Acids Concentration

average of free fatty acids measured every 30 minutes during the four hour fo each metabolic day

Time frame: average of 4 hours following intake of supplement

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantPlasma Free Fatty Acids Concentrationcontrol0.43 µmol/LStandard Error 0.05
Healthy ParticipantPlasma Free Fatty Acids Concentration10g MCT oil0.39 µmol/LStandard Error 0.04
Healthy ParticipantPlasma Free Fatty Acids Concentration20g MCT oil0.41 µmol/LStandard Error 0.04
Healthy ParticipantPlasma Free Fatty Acids Concentration30 g MCT oil0.38 µmol/LStandard Error 0.05
Healthy ParticipantPlasma Free Fatty Acids Concentration10g MCT homogenate0.44 µmol/LStandard Error 0.05
Healthy ParticipantPlasma Free Fatty Acids Concentration20g MCT homogeante0.41 µmol/LStandard Error 0.05
Healthy ParticipantPlasma Free Fatty Acids Concentration30g MCT homogenate0.5 µmol/LStandard Error 0.06
Secondary

Plasma Glucose Concentration

average of glucose measured every 30 minutes during the four hour of each metabolic day

Time frame: Average of every 30 minutes for 4 hours following intake of supplement

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantPlasma Glucose Concentration30g MCT oil4.99 mmol/LStandard Error 0.27
Healthy ParticipantPlasma Glucose Concentrationcontrol4.86 mmol/LStandard Error 0.33
Healthy ParticipantPlasma Glucose Concentration10 g MCT oil4.98 mmol/LStandard Error 0.24
Healthy ParticipantPlasma Glucose Concentration20g MCT oil4.97 mmol/LStandard Error 0.28
Healthy ParticipantPlasma Glucose Concentration10g MCT homogenate5.01 mmol/LStandard Error 0.26
Healthy ParticipantPlasma Glucose Concentration20g MCT homogenate4.84 mmol/LStandard Error 0.26
Healthy ParticipantPlasma Glucose Concentration30g MCT homogenate5.09 mmol/LStandard Error 0.22
Secondary

Plasma Insuline Concentration

Average of insulin measured evey 30 minutes during the 4 hours of each metabolic day

Time frame: average of 4 hours following intake of supplement

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantPlasma Insuline Concentration20 g MCT oil10.88 µIU/mLStandard Error 2.01
Healthy ParticipantPlasma Insuline Concentration30 g MCT oil13.00 µIU/mLStandard Error 2.58
Healthy ParticipantPlasma Insuline Concentrationcontrol9.79 µIU/mLStandard Error 2.03
Healthy ParticipantPlasma Insuline Concentration10g MCT oil13.7 µIU/mLStandard Error 3.43
Healthy ParticipantPlasma Insuline Concentration10g MCT homogenate12.87 µIU/mLStandard Error 2.47
Healthy ParticipantPlasma Insuline Concentration20g MCT homogenate11.94 µIU/mLStandard Error 2.84
Healthy ParticipantPlasma Insuline Concentration30g MCT homogenate12.86 µIU/mLStandard Error 2.08

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026