Prism Clinical Research
Saint Paul, Minnesota, 55114, United States
NCT Number: NCT04281758
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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Notify Me18 year–55 year
Male
Interventional
Phase 1
Saint Paul, Minnesota, 55114, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
16 oz (473.2 ml)
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
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
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
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
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
Plasma caffeine level
Time frame: At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose
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
VAS scale,16 terms, each rated on a 100 mm line. Example, relaxed is better than tense.
PepsiCo Global R&D
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.