Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic potential | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Dietary Supplement | Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen Cunnane, PhD | Research Centre on Aging CSSS-IUGS - CIUSSS de l'Estrie - CHUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) | Sherbrooke | Quebec | J1H4C4 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | µmol/L | 4 hours |
|
8 visits of 4 hours
no participants received the intervention if 65 g of butter fraction rich in MCT
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control, no Supplement | Each visit corresponding to a standardize breakfast taken alone (control visit)followed by a period of 4-hour with multiple blood sampling. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Stephen Cunnane | Université de Sherbrooke | 819-780-2220 | 45670 | stephen.cunnane@usherbrooke.ca |
Not provided
| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007930 | Leucine |
| D002087 | Butyrates |
| C031492 | octanoic acid |
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Leucine | Dietary Supplement | Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling. |
|
| Butyrate - | Dietary Supplement | Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling. |
|
| Butyrate + | Dietary Supplement | Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling. |
|
| Octanoate - | Dietary Supplement | Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling. |
|
| Octanoate + | Dietary Supplement | Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling. |
|
| Carnitine | Dietary Supplement | Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling. |
|
| Butter fraction | Dietary Supplement | Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 5g of Leucine | Each visit corresponding to a standardize breakfast taken with 5g of leucine followed by a period of 4-hour with multiple blood sampling. | 0 | 10 | 0 | 10 |
| EG002 | 3.6g de Butyrate | Each visit corresponding to a standardize breakfast taken with 3.6g of butyrate followed by a period of 4-hour with multiple blood sampling. | 0 | 10 | 2 | 10 |
| EG003 | 7.2g de Butyrate | Each visit corresponding to a standardize breakfast taken with 7.2g of butyrate followed by a period of 4-hour with multiple blood sampling. | 0 | 10 | 3 | 10 |
| EG004 | 5g d'Octanoate | Each visit corresponding to a standardize breakfast taken with 5g of octanoate followed by a period of 4-hour with multiple blood sampling. | 0 | 10 | 2 | 10 |
| EG005 | 10g d'Octanoate | Each visit corresponding to a standardize breakfast taken with 10g of octanoate followed by a period of 4-hour with multiple blood sampling. | 0 | 10 | 3 | 10 |
| EG006 | 1.95g de Carnitine | Each visit corresponding to a standardize breakfast taken with 1.95g of carnitine followed by a period of 4-hour with multiple blood sampling. | 0 | 10 | 0 | 10 |
| Headache | General disorders | Systematic Assessment |
|
| gastric reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |