Trial Outcomes & Findings for Comparing the Ketogenic Effect of Coconut Oil and Different MCTs (NCT NCT02679222)

NCT ID: NCT02679222

Last Updated: 2020-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

8 hours

Results posted on

2020-04-06

Participant Flow

Participant milestones

Participant milestones
Measure
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. Coconut oil: 20 g of coconut oil Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10) MCT: 20 g of MCT (60 of C8+40 of C10) Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin Tricaprylin: 20 g tricaprylin Tricaprin: 20 g tricaprin Control: No supplement taken on this visit
Overall Study
STARTED
10
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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. Coconut oil: 20 g of coconut oil Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10) MCT: 20 g of MCT (60 of C8+40 of C10) Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin Tricaprylin: 20 g tricaprylin Tricaprin: 20 g tricaprin Control: No supplement taken on this visit
Overall Study
No time for project
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Supplementation
n=9 Participants
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. Coconut oil: 20 g of coconut oil Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10) MCT: 20 g of MCT (60 of C8+40 of C10) Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin Tricaprylin: 20 g tricaprylin Tricaprin: 20 g tricaprin Control: No supplement taken on this visit
Age, Continuous
34 years
STANDARD_DEVIATION 12 • n=9 Participants
Sex: Female, Male
Female
4 Participants
n=9 Participants
Sex: Female, Male
Male
5 Participants
n=9 Participants
Region of Enrollment
Canada
9 Participants
n=9 Participants
Body mass index
24 kg/m^2
STANDARD_DEVIATION 3 • n=9 Participants
Glucose
4.3 mmol/L
STANDARD_DEVIATION 0.2 • n=9 Participants
Ketones
90 µmol/L
STANDARD_DEVIATION 61 • n=9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=9 Participants
vehicle (Control) taken twice, once at breakfast and once at mid-day. Control: No supplement taken on this visit
Medium Chain Triglyceride
n=9 Participants
20 mL of MCT taken twice, once at breakfast and once at mid-day. MCT: 20 g of MCT (60 of C8+40 of C10)
Tricaprin
n=9 Participants
20 mL of MCT tricaprin taken twice, once at breakfast and once at mid-day. Tricaprin: 20 g tricaprin
Tricaprylin
n=9 Participants
20 mL of tricaprylin taken twice, once at breakfast and once at mid-day. Tricaprylin: 20 g tricaprylin
Coconut Oil
n=9 Participants
20 mL of Coconut oil taken twice, once at breakfast and once at mid-day. Coconut oil: 20 g of coconut oil
Coconut Oil + MCT
n=9 Participants
20 mL of coconut oil + MCT taken twice, once at breakfast and once at mid-day. Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)
Coconut Oil + Tricaprylin
n=9 Participants
20 mL of Coconut oil + tricaprylin \[50:50\]) taken twice, once at breakfast and once at mid-day. Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin
Plasma Ketone Concentrations
69 µmol/L
Standard Deviation 92
294 µmol/L
Standard Deviation 85
109 µmol/L
Standard Deviation 41
363 µmol/L
Standard Deviation 109
107 µmol/L
Standard Deviation 97
141 µmol/L
Standard Deviation 39
235 µmol/L
Standard Deviation 79

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Control
n=9 Participants
vehicle (Control) taken twice, once at breakfast and once at mid-day. Control: No supplement taken on this visit
Medium Chain Triglyceride
n=9 Participants
20 mL of MCT taken twice, once at breakfast and once at mid-day. MCT: 20 g of MCT (60 of C8+40 of C10)
Tricaprin
n=9 Participants
20 mL of MCT tricaprin taken twice, once at breakfast and once at mid-day. Tricaprin: 20 g tricaprin
Tricaprylin
n=9 Participants
20 mL of tricaprylin taken twice, once at breakfast and once at mid-day. Tricaprylin: 20 g tricaprylin
Coconut Oil
n=9 Participants
20 mL of Coconut oil taken twice, once at breakfast and once at mid-day. Coconut oil: 20 g of coconut oil
Coconut Oil + MCT
n=9 Participants
20 mL of coconut oil + MCT taken twice, once at breakfast and once at mid-day. Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)
Coconut Oil + Tricaprylin
n=9 Participants
20 mL of Coconut oil + tricaprylin \[50:50\]) taken twice, once at breakfast and once at mid-day. Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin
Plasma Acetoacetate/Beta-hydroxybutyrate Ratio
7.7 Ratio
Standard Deviation 3.2
6.9 Ratio
Standard Deviation 1.5
7.7 Ratio
Standard Deviation 1.1
5.9 Ratio
Standard Deviation 1.0
9.5 Ratio
Standard Deviation 2.9
8.4 Ratio
Standard Deviation 1.3
8.1 Ratio
Standard Deviation 2.2

Adverse Events

Supplementation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr. Stephen Cunnane

Université de Sherbrooke

Phone: 819-780-2220

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place