An interventional study of Control and Leucine in Healthy Adults, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Basic science
Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.
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.
195 studies on the registry are indexed under Ketosis; 41 are open to participants now.
This study's enrollment of 13 is below the median of 24 across 156 interventional studies indexed under Ketosis.
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Exclusion Criteria:
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
Dietary Supplement: Control · Dietary Supplement: Leucine · Dietary Supplement: Butyrate - · Dietary Supplement: Butyrate + · Dietary Supplement: Octanoate - · Dietary Supplement: Octanoate + · Dietary Supplement: Carnitine · Dietary Supplement: Butter fraction
Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling.
Also known as: CTL
Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling.
Drug pages: Butyrates · Butyric Acid
Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling.
Drug pages: Butyrates · Butyric Acid
Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling.
Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling.
Drug page: Octanoic acid
Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling.
Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling.
Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling.
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
| Milestone | Ketogenic Potential |
|---|---|
| Started | 13 |
| Completed | 10 |
| Not completed | 3 |
| Withdrew: No time | 3 |
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.
| µmol/L | Ketogenic Potential |
|---|---|
| CTL | -18.2 ± 20 |
| Leucine | 23 ± 25 |
| Butyrate 3.6g | 12.2 ± 44.4 |
| Butyrate 7.2g | 68.5 ± 35.9 |
| Octanoate 5g | -3.4 ± 32.8 |
| Octanoate 10 g | 39.7 ± 34 |
| Carnitine | -30 ± 21.4 |
Collected over 8 visits of 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control, no Supplement | — | 0/10 (0%) | 0/10 (0%) |
| 5g of Leucine | — | 0/10 (0%) | 0/10 (0%) |
| 3.6g de Butyrate | — | 0/10 (0%) | 2/10 (20%) |
| 7.2g de Butyrate | — | 0/10 (0%) | 3/10 (30%) |
| 5g d'Octanoate | — | 0/10 (0%) | 2/10 (20%) |
| 10g d'Octanoate | — | 0/10 (0%) | 3/10 (30%) |
| 1.95g de Carnitine | — | 0/10 (0%) | 0/10 (0%) |
| Event | Control, no Supplement | 5g of Leucine | 3.6g de Butyrate | 7.2g de Butyrate | 5g d'Octanoate | 10g d'Octanoate | 1.95g de Carnitine |
|---|---|---|---|---|---|---|---|
| HeadacheGeneral disorders | 0/10 | 0/10 | 0/10 | 3/10 | 0/10 | 0/10 | 0/10 |
| gastric refluxGastrointestinal disorders | 0/10 | 0/10 | 0/10 | 0/10 | 2/10 | 3/10 | 0/10 |
| DiarrheaGastrointestinal disorders | 0/10 | 0/10 | 2/10 | 2/10 | 0/10 | 0/10 | 0/10 |
| NauseaGeneral disorders | 0/10 | 0/10 | 0/10 | 2/10 | 0/10 | 2/10 | 0/10 |
| Age, Categorical(Participants) | Ketogenic Potential |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 0 |
| Age, Continuous(years) | Ketogenic Potential |
|---|---|
| Mean | 34 ± 4 |
| Sex: Female, Male(Participants) | Ketogenic Potential |
|---|---|
| Female | 10 |
| Male | 3 |
| Region of Enrollment(Participants) | Ketogenic Potential |
|---|---|
| Canada | 13 |
Plan to share: Undecided
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Leucine · Butyrates · Butyric Acid · Octanoic acid · Carnitine