- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02679222
Comparing the Ketogenic Effect of Coconut Oil and Different MCTs (MCT-Coco)
March 23, 2020 updated by: Université de Sherbrooke
Comparing the Ketogenic Effect of Coconut Oil and Different Medium-chain Triglycerides
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.
Study Overview
Status
Completed
Conditions
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
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H4C4
- Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
20 g of coconut oil
Other Names:
10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)
Other Names:
20 g of MCT (60 of C8+40 of C10)
10 g coconut oil + 10 g tricaprylin
Other Names:
20 g tricaprylin
Other Names:
20 g tricaprin
Other Names:
No supplement taken on this visit
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Cunnane, PhD, CSSS-IUGS - CIUSSS de L'Estrie - CHUS - Université de Sherbrooke
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
February 1, 2016
First Submitted That Met QC Criteria
February 5, 2016
First Posted (Estimate)
February 10, 2016
Study Record Updates
Last Update Posted (Actual)
April 6, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016-541
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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