NCT02679222

Brief Summary

The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each oil are evaluated individually or in combination over a 8h-period during which repeated blood sampling is performed.

Trial Health

87
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

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 6, 2020

Completed
Last Updated

April 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

February 1, 2016

Results QC Date

February 11, 2019

Last Update Submit

March 23, 2020

Conditions

Keywords

KetonesCoconut oilMedium Chain Triglycerides

Outcome Measures

Primary Outcomes (1)

  • Plasma Ketone Concentrations

    Total ketones = Plasma acetoacetate (µmol/L) + beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e. daily mean). Samples are taken every 30 minutes on a 8 hours period. The mean is reported here.

    8 hours

Secondary Outcomes (1)

  • Plasma Acetoacetate/Beta-hydroxybutyrate Ratio

    8 hours

Study Arms (1)

Supplementation

EXPERIMENTAL

Protocol involved seven separate but identical metabolic study days for each participant. the test substances were evaluated in random order: vehicle (Control) or 20 mL of the test oils (Coconut oil; tricaprin; tricaprylin; MCT \[tricaprylin/tricaprin\]; coconut oil + MCT \[50:50\]; Coconut oil + tricaprylin \[50:50\]) taken twice, once at breakfast and once at mid-day.

Dietary Supplement: Coconut oilDietary Supplement: Coconut oil + MCTDietary Supplement: MCTDietary Supplement: Coconut oil + tricaprylinDietary Supplement: TricaprylinDietary Supplement: TricaprinDietary Supplement: Control

Interventions

Coconut oilDIETARY_SUPPLEMENT

20 g of coconut oil

Also known as: Coco
Supplementation
Coconut oil + MCTDIETARY_SUPPLEMENT

10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)

Also known as: Coco+MCT
Supplementation
MCTDIETARY_SUPPLEMENT

20 g of MCT (60 of C8+40 of C10)

Supplementation
Coconut oil + tricaprylinDIETARY_SUPPLEMENT

10 g coconut oil + 10 g tricaprylin

Also known as: Coco+C8
Supplementation
TricaprylinDIETARY_SUPPLEMENT

20 g tricaprylin

Also known as: C8
Supplementation
TricaprinDIETARY_SUPPLEMENT

20 g tricaprin

Also known as: C10
Supplementation
ControlDIETARY_SUPPLEMENT

No supplement taken on this visit

Also known as: CTL
Supplementation

Eligibility Criteria

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

You may qualify if:

  • Healthy adult over 18 y old.

You may not qualify if:

  • Fasting plasma glucose ≥7.0 mM (diabetics or pre-diabetics);
  • Smoking
  • Clinically-significant gastro-intestinal disease/conditions.
  • Clinically-significant liver disease/dysfunction.
  • Clinically-significant cardiac disease/conditions.
  • Clinically-significant abnormal coagulation.
  • Taking a medication that could affect lipid and glucose metabolism
  • Hypertension
  • Pregnancy or breastfeeding
  • Exercising more than 3 times a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Sherbrooke, Quebec, J1H4C4, Canada

Location

MeSH Terms

Conditions

Ketosis

Interventions

Coconut OiltricaprylintricaprinNeprilysin

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOilsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesAntigens, NeoplasmAntigensBiological FactorsBiomarkers, TumorBiomarkers

Results Point of Contact

Title
Pr. Stephen Cunnane
Organization
Université de Sherbrooke

Study Officials

  • Stephen Cunnane, PhD

    CSSS-IUGS - CIUSSS de L'Estrie - CHUS - 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 10, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

April 6, 2020

Results First Posted

April 6, 2020

Record last verified: 2020-03

Locations