NCT02409927

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

December 17, 2018

Completed
Last Updated

February 11, 2019

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

March 27, 2015

Results QC Date

August 29, 2017

Last Update Submit

January 28, 2019

Conditions

Keywords

Medium-chain triglyceridesMetabolismKetonesLipidsEmulsification

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Plasma Glucose Concentration

    Average of every 30 minutes for 4 hours following intake of supplement

  • Plasma Free Fatty Acids Concentration

    average of 4 hours following intake of supplement

  • Plasma Insuline Concentration

    average of 4 hours following intake of supplement

  • Number of Participants With Side Effects for Each Visit

    During the 4 hours following intake of supplement

Study Arms (1)

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)

Dietary Supplement: MCT oil 10gDietary Supplement: MCT homogenate 10gDietary Supplement: ControlDietary Supplement: MCT oil 20gDietary Supplement: MCT homogenate 20gDietary Supplement: MCT oil 30gDietary Supplement: MCT homogenate 30g

Interventions

MCT oil 10gDIETARY_SUPPLEMENT

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

Healthy participant
MCT homogenate 10gDIETARY_SUPPLEMENT

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

Healthy participant
ControlDIETARY_SUPPLEMENT

vehicule (skim milk) with a standardized breakfast

Healthy participant
MCT oil 20gDIETARY_SUPPLEMENT

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

Healthy participant
MCT homogenate 20gDIETARY_SUPPLEMENT

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

Healthy participant
MCT oil 30gDIETARY_SUPPLEMENT

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

Healthy participant
MCT homogenate 30gDIETARY_SUPPLEMENT

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

Healthy participant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Pr. Stephen Cunnane
Organization
Université de Sherbrooke

Study Officials

  • Stephen C Cunnane, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Each participant underwent 7 metabolic day (1-day visit), each visit separate by a minimum of 3 day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 7, 2015

Study Start

July 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 11, 2019

Results First Posted

December 17, 2018

Record last verified: 2015-05