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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
16
16 oz (473.2 ml)
Prism Clinical Research
Saint Paul, Minnesota, United States
Incremental area-under-the-concentration-curve (iAUC)
Plasma caffeine level
Time frame: 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
Caffeine concentration
Plasma caffeine level
Time frame: 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)
Plasma caffeine level
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose
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