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Comparing the Ketogenic Effect of Coconut Oil and Different MCTs (MCT-Coco)

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ClinicalTrials.gov Identifier: NCT02679222
Recruitment Status : Completed
First Posted : February 10, 2016
Results First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

Tracking Information
First Submitted Date  ICMJE February 1, 2016
First Posted Date  ICMJE February 10, 2016
Results First Submitted Date  ICMJE February 11, 2019
Results First Posted Date  ICMJE April 6, 2020
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
Plasma Ketone Concentrations [ Time Frame: 8 hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
Plasma Ketone Concentrations [ Time Frame: 8 hours ]
Acetoacetate (uM) and beta-hydroxybutyrate (uM)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
Plasma Acetoacetate/Beta-hydroxybutyrate Ratio [ Time Frame: 8 hours ]
Plasma ratio of acetoacetate (µmol/L)/ beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e area-under-the-curve over 8 hours).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
  • Plasma glucose concentrations [ Time Frame: 8 hours ]
    Glucose (mM)
  • Plasma cholesterol concentrations [ Time Frame: 8 hours ]
    Total cholesterol (mM)
  • Plasma free fatty acid concentrations [ Time Frame: 8 hours ]
    Triglycerides (mM)
  • Plasma triglyceride concentrations [ Time Frame: 8 hours ]
    Triglycerides (mM)
  • Plasma insulin concentrations [ Time Frame: 8 hours ]
    Insulin (IU/L)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Ketogenic Effect of Coconut Oil and Different MCTs
Official Title  ICMJE Comparing the Ketogenic Effect of Coconut Oil and Different Medium-chain Triglycerides
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.
Detailed Description The study is composed of eight successive visits. Each visit consists of the consumption of one individual oil or a mixture of oils (20 g of coconut oil or 10 g of coconut oil + 10 g of MCT 60-40 or 20 g MCT 60-40 or 10 g coconut oil + 10 g tricaprylin or 20 g tricaprylin or 10 g coconut oil + 10 g triheptanoate or 20 g triheptanoate) and a 8h follow-up during which repeated blood samples are taken for laboratory analysis (plasma beta-hydroxybutyrate, acetoacetate, glucose, free fatty acids, triglycerides, total cholesterol, lactate and insulin).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Adults
Intervention  ICMJE
  • Dietary Supplement: Coconut oil
    20 g of coconut oil
    Other Name: Coco
  • Dietary Supplement: Coconut oil + MCT
    10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)
    Other Name: Coco+MCT
  • Dietary Supplement: MCT
    20 g of MCT (60 of C8+40 of C10)
  • Dietary Supplement: Coconut oil + tricaprylin
    10 g coconut oil + 10 g tricaprylin
    Other Name: Coco+C8
  • Dietary Supplement: Tricaprylin
    20 g tricaprylin
    Other Name: C8
  • Dietary Supplement: Tricaprin
    20 g tricaprin
    Other Name: C10
  • Dietary Supplement: Control
    No supplement taken on this visit
    Other Name: CTL
Study Arms  ICMJE Experimental: Supplementation
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.
Interventions:
  • Dietary Supplement: Coconut oil
  • Dietary Supplement: Coconut oil + MCT
  • Dietary Supplement: MCT
  • Dietary Supplement: Coconut oil + tricaprylin
  • Dietary Supplement: Tricaprylin
  • Dietary Supplement: Tricaprin
  • Dietary Supplement: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adult over 18 y old.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02679222
Other Study ID Numbers  ICMJE 2016-541
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Université de Sherbrooke
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Cunnane, PhD CSSS-IUGS - CIUSSS de L'Estrie - CHUS - Université de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP