NCT04281758

Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: PepsiCo Global R&D · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Plasma Caffeine Concentration

Interventions

Type	Name	Description
OTHER	Beverage	16 oz (473.2 ml)

Timeline

• Start date: 2020-07-20
• Primary completion: 2020-10-01
• Completion: 2020-10-13
• First posted: 2020-02-24
• Last updated: 2020-10-30

Locations

1 site across 1 country: United States