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This study is designed to compare self-reported mood states for encapsulated caffeine compared to dose-matched free caffeine, when consumed as a ready-to-drink beverage in healthy subjects. Additionally, this study will characterize the plasma caffeine pharmacokinetic profile for the encapsulated and free caffeine beverages. Two different caffeine levels, 160 and 250 mg will be included, which represent more common caffeine consumption from typical energy drinks.
The primary outcomes are alertness ratings from the Caffeine Research visual analog scale (VAS) and PK parameters over 12 hours. Secondary outcomes are Caffeine Research VAS scores (beyond alertness), three other symptom VAS scores, and vital signs for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beverage 1 | Active Comparator | Free caffeine 160 mg |
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| Beverage 2 | Experimental | Encapsulated caffeine 160 mg |
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| Beverage 3 | Active Comparator | Free caffeine 250 mg |
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| Beverage 4 | Experimental | Encapsulated caffeine 250 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavored caffeinated beverage | Other | 16.9 oz (500 cc), carbonated, zero calorie |
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| Measure | Description | Time Frame |
|---|---|---|
| Alertness | A self-reported mood measurement from the Caffeine Research Visual Analog Scale (VAS) rated from 0 (not at all) to 100 mm (extremely alert), to compare dose-matched free caffeine to encapsulated caffeine. Longer-lasting alertness would be a benefit. | Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion |
| Plasma caffeine PK profile of (AUC0-t, AUC0-inf) | Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine (AUC0-t, AUC0-inf) | Changes from pre-dose baseline to 12 hours after the first sip of beverage. |
| Plasma caffeine PK profile of peak caffeine concentration (Cmax) | Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine peak caffeine concentration (Cmax) | Changes from pre-dose baseline to 12 hours after the first sip of beverage. |
| Plasma caffeine PK profile of time to maximal plasma caffeine concentration (Tmax) | Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine time to maximal plasma caffeine concentration (Tmax) | Changes from pre-dose baseline to 12 hours after the first sip of beverage. |
| Plasma caffeine PK profile of half-life (t1/2) |
| Measure | Description | Time Frame |
|---|---|---|
| The 6 other Caffeine Research Visual Analog Scale (VAS) symptom ratings besides alertness | Self-reported Caffeine Research Visual Analog Scale (VAS) ratings from 0-100 mm representing the full range of each dimension (relaxed, jittery, tired, tense, headache, overall mood) to compare dose-matched free caffeine to encapsulated caffeine. More relaxed, less jittery, less tired, less tense, no headache and better mood would be better. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they have:
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| Name | Affiliation | Role |
|---|---|---|
| Swarna Yadlapalli, MD | Medical Director, Axis Clinicals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AXIS Clinicals | Dilworth | Minnesota | 56529 | United States |
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Double-blinded
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine half-life (t1/2)
| Changes from pre-dose baseline to 12 hours after the first sip of beverage. |
| Plasma caffeine PK profile of plasma caffeine concentration by time | Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine concentration by time | Changes from pre-dose baseline to 12 hours after the first sip of beverage. |
| Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion |
| 3 additional other symptoms Visual Analog Scale (VAS) ratings | Self-reported caffeine symptoms (lightheaded, irritable, pounding heartbeat) rated on a Visual Analog Scale (VAS) from 0 (not at all) to 100 mm (extremely) to compare dose-matched free caffeine to encapsulated caffeine. Absence of these would be better. | Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion |
| Blood pressure | Vital sign for safety monitoring. Resting blood pressures within normal limits would be better. | Changes from pre-dose baseline to 2 and 6 hours post beverage ingestion |
| Heart rate | Vital sign for safety monitoring. Resting heart rates within normal limits would be better. | Changes from pre-dose baseline to 2 and 6 hours post beverage ingestion |