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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participant | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCT oil 10g | Dietary Supplement | 10 g of pure MCT oil mixed with skim milk in a standardized breakfast |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen C Cunnane, PhD | Université de Sherbrooke | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29955713 | Derived | Courchesne-Loyer A, Lowry CM, St-Pierre V, Vandenberghe C, Fortier M, Castellano CA, Wagner JR, Cunnane SC. Emulsification Increases the Acute Ketogenic Effect and Bioavailability of Medium-Chain Triglycerides in Humans: Protein, Carbohydrate, and Fat Metabolism. Curr Dev Nutr. 2017 Jun 21;1(7):e000851. doi: 10.3945/cdn.117.000851. eCollection 2017 Jul. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | µmol/L | Average of every 30 minutes for 4 hours following intake of supplement |
|
|
Adverse event date were collected during the 7 metabolic study day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Stephen Cunnane | Université de Sherbrooke | 819-780-2220 | 45670 | stephen.cunnane@usherbrooke.ca |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Each participant underwent 7 metabolic day (1-day visit), each visit separate by a minimum of 3 day
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| MCT homogenate 10g | Dietary Supplement | 10g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast |
|
| Control | Dietary Supplement | vehicule (skim milk) with a standardized breakfast |
|
| MCT oil 20g | Dietary Supplement | 20g of pure MCT oil mixed with skim milk in a standardized breakfast |
|
| MCT homogenate 20g | Dietary Supplement | 20g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast |
|
| MCT oil 30g | Dietary Supplement | 30g of 100% pure MCT oil mixed with skim milk in a standardized breakfast |
|
| MCT homogenate 30g | Dietary Supplement | 30g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast |
|
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 |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Plasma Glucose Concentration | average of glucose measured every 30 minutes during the four hour of each metabolic day | Posted | Mean | Standard Error | mmol/L | Average of every 30 minutes for 4 hours following intake of supplement |
|
|
|
| Secondary | Plasma Free Fatty Acids Concentration | average of free fatty acids measured every 30 minutes during the four hour fo each metabolic day | Posted | Mean | Standard Error | µmol/L | average of 4 hours following intake of supplement |
|
|
|
| Secondary | Plasma Insuline Concentration | Average of insulin measured evey 30 minutes during the 4 hours of each metabolic day | Posted | Mean | Standard Error | µIU/mL | average of 4 hours following intake of supplement |
|
|
|
| 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. | Posted | Count of Participants | Participants | During the 4 hours following intake of supplement |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| gastric reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| 30g MCT oil |
|
| 10g MCT homogenate |
|
| 20g MCT homogenate |
|
| 30g MCT homogenate |
|
| Title | Measurements |
|---|---|
|
| 30 g MCT oil |
|
| 10g MCT homogenate |
|
| 20g MCT homogeante |
|
| 30g MCT homogenate |
|
| Title | Measurements |
|---|---|
|
| 30 g MCT oil |
|
| 10g MCT homogenate |
|
| 20g MCT homogenate |
|
| 30g MCT homogenate |
|
| Title | Measurements |
|---|---|
|
| 30 g MCT oil |
|
| 10 g MCT homogenate |
|
| 20g MCT homogenate |
|
| 30g MCT homogenate |
|