Healthy Adults
Conditions
Keywords
Ketones, Butyrate, Leucine, Octanoate, Carnitine, Medium Chain Triglycerides
Brief summary
Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.
Detailed description
The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production.
Interventions
DIETARY_SUPPLEMENTControl
Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling.
DIETARY_SUPPLEMENTLeucine
Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling.
DIETARY_SUPPLEMENTButyrate -
Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling.
DIETARY_SUPPLEMENTButyrate +
Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling.
DIETARY_SUPPLEMENTOctanoate -
Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling.
DIETARY_SUPPLEMENTOctanoate +
Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling.
DIETARY_SUPPLEMENTCarnitine
Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling.
DIETARY_SUPPLEMENTButter fraction
Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling.
Sponsors
Université de Sherbrooke
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults aged of 18 years old or older. * Non-smoking.
Exclusion criteria
* Diabetes or prediabetes * Uncontrolled hypertension * Uncontrolled thyroid function * Taking medication that will affect lipid/glucose metabolism * Severe infection or inflammation * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Total Plasma Ketones | 4 hours | Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast. Plasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken). Results are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period. For each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones. Data were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketogenic Potential Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.
Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No time | 3 |
Baseline characteristics
| Characteristic | Ketogenic Potential |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 4 |
| Region of Enrollment Canada | 13 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 2 / 10 | 3 / 10 | 2 / 10 | 3 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Concentration of Total Plasma Ketones
Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast. Plasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken). Results are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period. For each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones. Data were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement.
Time frame: 4 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketogenic Potential | Concentration of Total Plasma Ketones | CTL | -18.2 µmol/L | Standard Error 20 |
| Ketogenic Potential | Concentration of Total Plasma Ketones | Leucine | 23 µmol/L | Standard Error 25 |
| Ketogenic Potential | Concentration of Total Plasma Ketones | Butyrate 3.6g | 12.2 µmol/L | Standard Error 44.4 |
| Ketogenic Potential | Concentration of Total Plasma Ketones | Butyrate 7.2g | 68.5 µmol/L | Standard Error 35.9 |
| Ketogenic Potential | Concentration of Total Plasma Ketones | Octanoate 5g | -3.4 µmol/L | Standard Error 32.8 |
| Ketogenic Potential | Concentration of Total Plasma Ketones | Octanoate 10 g | 39.7 µmol/L | Standard Error 34 |
| Ketogenic Potential | Concentration of Total Plasma Ketones | Carnitine | -30 µmol/L | Standard Error 21.4 |