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Completed

NCT Number: NCT02409927

Effect of MCT Emulsification on Ketogenesis in Human Adults

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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Key information

Conditions

Healthy Acid-Base Imbalance Acidosis Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCT oil 10g

Dietary Supplement

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

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

Primary outcomes

  1. Plasma Ketone Concentration

    Time frame: 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 outcomes

  1. Plasma Glucose Concentration

    Time frame: 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

  2. Plasma Free Fatty Acids Concentration

    Time frame: 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

  3. Plasma Insuline Concentration

    Time frame: average of 4 hours following intake of supplement

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

  4. Number of Participants With Side Effects for Each Visit

    Time frame: During the 4 hours following intake of supplement

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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 7, 2015
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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