A Phase 1 interventional study of Beverage in Plasma Caffeine Concentration, sponsored by PepsiCo Global R&D. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-30.
Sponsored by PepsiCo Global R&D · Phase 1, Interventional, and Basic science
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.
PepsiCo Global R&D is the lead sponsor of 101 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Flavored still beverage with caffeine 100 mg
Other: Beverage
Flavored still beverage with caffeine 100 mg + quercetin 250 mg
Other: Beverage
Flavored still beverage with caffeine 100 mg + curcumin 80 mg
Other: Beverage
Flavored still beverage with caffeine 100 mg + methylliberine 75 mg
Other: Beverage
16 oz (473.2 ml)
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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PepsiCo Global R&D