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Evaluate the effect of a caffeine supplement on the stimulation of lipolysis and the production of ketones in healthy adults (N=10).
The aim of the study is to evaluate the effect of a caffeine supplement on the stimulation of lipolysis and the production of ketones in healthy adults (N=10). Two different doses of caffeine (2.5 mg/kg of BW and 5 mg/kg of BW) are compared. All the participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketonemia following caffeine intake | Experimental | Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5.0 mg/kg of MW) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Dietary Supplement | 4-hour visit with no caffeine is given during a standardize breakfast follow by repeated blood sampling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Acetoacetate Concentrations | Plasma acetoacetate (µmol/L) measured over a 4 hour period. | 4 hours |
| Plasma Beta-hydroxybutyrate Concentrations | Plasma beta-hydroxybutyrate (µmol/L) measured over a 4 hour period. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose Concentrations | Plasma glucose (mmol/L) measured over a 4 hour period. | 4 hours |
| Plasma Cholesterol Concentrations | Plasma cholesterol (mmol/L) measured over a 4 hour period. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketonemia Following Caffeine Intake | Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketonemia Following Caffeine Intake | Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW) |
| 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 | Plasma Acetoacetate Concentrations | Plasma acetoacetate (µmol/L) measured over a 4 hour period. | Posted | Mean | Standard Error | µmol/L | 4 hours |
|
|
3 visits of 4 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketonemia Following Caffeine Intake = Intervention 1: Control; no Caffeine Intake | Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Stephen Cunnane | Université de Sherbrooke | 819-780-2220 | 45670 | stephen.cunnane@usherbrooke.ca |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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|
| Caffeine low dose | Dietary Supplement | 4-hour visit with a dose of 2.5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling. |
|
| Caffeine high dose | Dietary Supplement | 4-hour visit with a dose of 5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling. |
|
| 4 hours |
| Plasma Triglyceride Concentrations | Plasma triglycerides (mmol/L) measured over a 4 hour period. | 4 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Plasma Beta-hydroxybutyrate Concentrations | Plasma beta-hydroxybutyrate (µmol/L) measured over a 4 hour period. | Posted | Mean | Standard Error | µmol/L | 4 hours |
|
|
|
| Secondary | Plasma Glucose Concentrations | Plasma glucose (mmol/L) measured over a 4 hour period. | Posted | Mean | Standard Error | mmol/L | 4 hours |
|
|
|
| Secondary | Plasma Cholesterol Concentrations | Plasma cholesterol (mmol/L) measured over a 4 hour period. | Posted | Mean | Standard Error | mmol/L | 4 hours |
|
|
|
| Secondary | Plasma Triglyceride Concentrations | Plasma triglycerides (mmol/L) measured over a 4 hour period. | Posted | Mean | Standard Error | mmol/L | 4 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Ketonemia Following Caffeine Intake = Intervention 2: Caffeine Low Dose (2.5 mg/kg of BW) | Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW) | 0 | 10 | 0 | 10 |
| EG002 | Ketonemia Following Caffeine Intake = Intervention 3: Caffeine High Dose (5 mg/kg of BW) | Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW) | 0 | 10 | 0 | 10 |
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
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