Trial Outcomes & Findings for Effect of MCT Emulsification on Ketogenesis in Human Adults (NCT NCT02409927)
NCT ID: NCT02409927
Last Updated: 2019-02-11
Results Overview
Average of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Average of every 30 minutes for 4 hours following intake of supplement
Results posted on
2019-02-11
Participant Flow
Participant milestones
| Measure |
Healthy Participant
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)
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of MCT Emulsification on Ketogenesis in Human Adults
Baseline characteristics by cohort
| Measure |
Healthy
n=10 Participants
Participants involved in the project had seven metabolic study day to do : control day (no supplement), MCT oil 10,20 or 30 g, and MCT homogenate 10, 20 or 30 g. They were taking the supplement with a breakfast and there was blood sampling every 30 minutes.t
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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31 years
STANDARD_DEVIATION 3 • n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Region of Enrollment
Canada
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Average of every 30 minutes for 4 hours following intake of supplementAverage of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements
Outcome measures
| Measure |
Healthy Participant
n=10 Participants
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)
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|---|---|
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Plasma Ketone Concentration
control
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136.97 µmol/L
Standard Error 11.33
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Plasma Ketone Concentration
10g MCT oil
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177.43 µmol/L
Standard Error 14.711
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Plasma Ketone Concentration
20 g MCT oil
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270.61 µmol/L
Standard Error 27.477
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Plasma Ketone Concentration
30 g MCT oil
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249.3 µmol/L
Standard Error 17.474
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Plasma Ketone Concentration
10g MCT homogenate
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262.92 µmol/L
Standard Error 26.82
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Plasma Ketone Concentration
20g MCT homogenate
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277.25 µmol/L
Standard Error 30.006
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Plasma Ketone Concentration
30 g MCT homogenate
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244.74 µmol/L
Standard Error 65.83
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SECONDARY outcome
Timeframe: Average of every 30 minutes for 4 hours following intake of supplementaverage of glucose measured every 30 minutes during the four hour of each metabolic day
Outcome measures
| Measure |
Healthy Participant
n=10 Participants
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)
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|---|---|
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Plasma Glucose Concentration
control
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4.86 mmol/L
Standard Error 0.33
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Plasma Glucose Concentration
10 g MCT oil
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4.98 mmol/L
Standard Error 0.24
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Plasma Glucose Concentration
20g MCT oil
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4.97 mmol/L
Standard Error 0.28
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Plasma Glucose Concentration
30g MCT oil
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4.99 mmol/L
Standard Error 0.27
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Plasma Glucose Concentration
10g MCT homogenate
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5.01 mmol/L
Standard Error 0.26
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Plasma Glucose Concentration
20g MCT homogenate
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4.84 mmol/L
Standard Error 0.26
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Plasma Glucose Concentration
30g MCT homogenate
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5.09 mmol/L
Standard Error 0.22
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SECONDARY outcome
Timeframe: average of 4 hours following intake of supplementaverage of free fatty acids measured every 30 minutes during the four hour fo each metabolic day
Outcome measures
| Measure |
Healthy Participant
n=10 Participants
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)
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|---|---|
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Plasma Free Fatty Acids Concentration
control
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0.43 µmol/L
Standard Error 0.05
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Plasma Free Fatty Acids Concentration
10g MCT oil
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0.39 µmol/L
Standard Error 0.04
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Plasma Free Fatty Acids Concentration
20g MCT oil
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0.41 µmol/L
Standard Error 0.04
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Plasma Free Fatty Acids Concentration
30 g MCT oil
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0.38 µmol/L
Standard Error 0.05
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Plasma Free Fatty Acids Concentration
10g MCT homogenate
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0.44 µmol/L
Standard Error 0.05
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Plasma Free Fatty Acids Concentration
20g MCT homogeante
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0.41 µmol/L
Standard Error 0.05
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Plasma Free Fatty Acids Concentration
30g MCT homogenate
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0.5 µmol/L
Standard Error 0.06
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SECONDARY outcome
Timeframe: average of 4 hours following intake of supplementAverage of insulin measured evey 30 minutes during the 4 hours of each metabolic day
Outcome measures
| Measure |
Healthy Participant
n=10 Participants
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)
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|---|---|
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Plasma Insuline Concentration
control
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9.79 µIU/mL
Standard Error 2.03
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Plasma Insuline Concentration
10g MCT oil
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13.7 µIU/mL
Standard Error 3.43
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Plasma Insuline Concentration
20 g MCT oil
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10.88 µIU/mL
Standard Error 2.01
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Plasma Insuline Concentration
30 g MCT oil
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13.00 µIU/mL
Standard Error 2.58
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Plasma Insuline Concentration
10g MCT homogenate
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12.87 µIU/mL
Standard Error 2.47
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Plasma Insuline Concentration
20g MCT homogenate
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11.94 µIU/mL
Standard Error 2.84
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Plasma Insuline Concentration
30g MCT homogenate
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12.86 µIU/mL
Standard Error 2.08
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SECONDARY outcome
Timeframe: During the 4 hours following intake of supplementIf participant had any side effect (mild or moderate) at least one time during the day.
Outcome measures
| Measure |
Healthy Participant
n=10 Participants
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)
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|---|---|
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Number of Participants With Side Effects for Each Visit
30 g MCT oil
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5 Participants
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Number of Participants With Side Effects for Each Visit
control
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0 Participants
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Number of Participants With Side Effects for Each Visit
10 g MCT oil
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1 Participants
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Number of Participants With Side Effects for Each Visit
20 g MCT oil
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4 Participants
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Number of Participants With Side Effects for Each Visit
10 g MCT homogenate
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2 Participants
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Number of Participants With Side Effects for Each Visit
20g MCT homogenate
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4 Participants
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Number of Participants With Side Effects for Each Visit
30g MCT homogenate
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5 Participants
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Adverse Events
Healthy Participant
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Participant
n=10 participants at risk
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)
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|---|---|
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Gastrointestinal disorders
Abnominal discomfort
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20.0%
2/10 • Adverse event date were collected during the 7 metabolic study day
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Metabolism and nutrition disorders
Decreased appetite
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10.0%
1/10 • Adverse event date were collected during the 7 metabolic study day
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Gastrointestinal disorders
gastric reflux
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20.0%
2/10 • Adverse event date were collected during the 7 metabolic study day
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General disorders
Nausea
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20.0%
2/10 • Adverse event date were collected during the 7 metabolic study day
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Gastrointestinal disorders
Diarrhea
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0.00%
0/10 • Adverse event date were collected during the 7 metabolic study day
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General disorders
Headache
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0.00%
0/10 • Adverse event date were collected during the 7 metabolic study day
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place