NCT05096780

Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage and Associated Mood and Physiological Effects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: PepsiCo Global R&D · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to compare self-reported mood states for encapsulated caffeine compared to dose-matched free caffeine, when consumed as a ready-to-drink beverage in healthy subjects. Additionally, this study will characterize the plasma caffeine pharmacokinetic profile for the encapsulated and free caffeine beverages. Two different caffeine levels, 160 and 250 mg will be included, which represent more common caffeine consumption from typical energy drinks. The primary outcomes are alertness ratings from the Caffeine Research visual analog scale (VAS) and PK parameters over 12 hours. Secondary outcomes are Caffeine Research VAS scores (beyond alertness), three other symptom VAS scores, and vital signs for safety.

Conditions

• Alertness

Interventions

Type	Name	Description
OTHER	Flavored caffeinated beverage	16.9 oz (500 cc), carbonated, zero calorie

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-02-06
• Completion: 2022-02-06
• First posted: 2021-10-27
• Last updated: 2022-03-24

Locations

1 site across 1 country: United States