Clinical trial NCT02409927: Effect of MCT Emulsification on Ketogenesis in Human Adults
Official title: Effect of Medium-chain Triglycerides Emulsification on Ketogenesis and Adverse Effects in Human Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Medium-chain triglycerides
Metabolism
Ketones
Lipids
Emulsification
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant underwent 7 metabolic day (1-day visit), each visit separate by a minimum of 3 day
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Ketone Concentration
timeFrame: Average of every 30 minutes for 4 hours following intake of supplement
Secondary outcomes:
measure: Plasma Glucose Concentration
timeFrame: Average of every 30 minutes for 4 hours following intake of supplement
measure: Plasma Free Fatty Acids Concentration
timeFrame: average of 4 hours following intake of supplement
measure: Plasma Insuline Concentration
timeFrame: average of 4 hours following intake of supplement
measure: Number of Participants With Side Effects for Each Visit
timeFrame: During the 4 hours following intake of supplement
Other outcomes:
Locations:
Study officials:
affiliation: Université de Sherbrooke
name: Stephen C Cunnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.