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This is a Phase 1, double blind, randomized, controlled, cross-over trial.
The primary outcome is to quantify the incremental area-under-the-concentration-curve (iAUC) for plasma caffeine after oral consumption of caffeinated beverages with various bioactive compounds vs. caffeine alone, in 16 healthy volunteers
Secondary outcomes are caffeine concentration at each time point from pre-dose baseline to 3.5 hrs post-dose, peak caffeine concentration (Cmax), time to maximum caffeine concentration (Tmax) and return to baseline concentration (TBR) for plasma caffeine
Other outcomes are ratings of physiological symptoms and mood, assessed using visual analog scales (VAS).
Polyphenol food frequency questionnaire data at screening will be collected as a possible co-variate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine beverage (control) | Active Comparator | Flavored still beverage with caffeine 100 mg |
|
| Caffeine beverage plus bioactive 1 | Experimental | Flavored still beverage with caffeine 100 mg + quercetin 250 mg |
|
| Caffeine beverage plus bioactive 2 | Experimental | Flavored still beverage with caffeine 100 mg + curcumin 80 mg |
|
| Caffeine beverage plus bioactive 3 | Experimental | Flavored still beverage with caffeine 100 mg + methylliberine 75 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beverage | Other | 16 oz (473.2 ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area-under-the-concentration-curve (iAUC) | Plasma caffeine level | At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Caffeine concentration | Plasma caffeine level | At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose |
| Peak caffeine concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trisha R Shamp, PhD | Prism Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Clinical Research | Saint Paul | Minnesota | 55114 | United States |
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Beverage types are as similar as possible in terms of taste, aroma and color.
Plasma caffeine level
| At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose |
| Time to maximum concentration (Tmax) | Plasma caffeine level | At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose |
| Return to baseline concentration (TBR) | Plasma caffeine level | At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose |
| Physiological Symptoms | VAS scale, 9 terms, each rated on a 100 mm line from "Not at all" to "Extremely'. Example, not at all irritable is better than extremely irritable. | At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose |
| Bond-Lader Mood | VAS scale,16 terms, each rated on a 100 mm line. Example, relaxed is better than tense. | At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose |
| ID | Term |
|---|---|
| D001628 | Beverages |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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