Effect of MCT Emulsification on Ketogenesis in Human Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Each participant underwent 7 metabolic day (1-day visit), each visit separate by a minimum of 3 day
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy participant<br>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<br>* 10 g of pure MCT oil mixed with skim milk in a standardized breakfast<br>Dietary Supplement: MCT homogenate 10g<br>* 10g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast<br>Dietary Supplement: Control<br>* vehicule (skim milk) with a standardized breakfast<br>Dietary Supplement: MCT oil 20g<br>* 20g of pure MCT oil mixed with skim milk in a standardized breakfast<br>Dietary Supplement: MCT homogenate 20g<br>* 20g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast<br>Dietary Supplement: MCT oil 30g<br>* 30g of 100% pure MCT oil mixed with skim milk in a standardized breakfast<br>Dietary Supplement: MCT homogenate 30g<br>* 30g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Average of every 30 minutes for 4 hours following intake of supplement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose Concentration | 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 | 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 | 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 | If participant had any side effect (mild or moderate) at least one time during the day. | During the 4 hours following intake of supplement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medium-chain triglycerides, Metabolism, Ketones, Lipids, Emulsification