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NCT05096780 · ClinicalTrials.gov registry record · Phase 1
Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage and Associated Mood and Physiological Effects
A Phase 1 study of Alertness, sponsored by PepsiCo Global R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT05096780 is a Phase 1 study of Alertness that has completed, run by PepsiCo Global R&D. The registered enrollment target is 75 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05096780, a Phase 1 study of Alertness, has completed, sponsored by PepsiCo Global R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Flavored caffeinated beverage
Study Locations (1)
Minnesota
- AXIS Clinicals - Dilworth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2021-10-08 |
| Est. Completion | 2022-02-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05096780
The ClinicalTrials.gov registry entry for NCT05096780 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PepsiCo Global R&D, which has 47 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alertness appearing as the primary indexed condition, and to 1 intervention - of which Flavored caffeinated beverage is the first listed.
NCT05096780 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT05096780 about?
NCT05096780 is a clinical study titled "Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage and Associated Mood and Physiological Effects". 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 an...
What is the current status of trial NCT05096780?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2021-10-08. Estimated completion is 2022-02-06.
What conditions does trial NCT05096780 study?
This clinical trial studies the following conditions: Alertness.
What interventions are being tested in trial NCT05096780?
The interventions under investigation include: Flavored caffeinated beverage (OTHER).
Who is sponsoring clinical trial NCT05096780?
This trial is sponsored by PepsiCo Global R&D, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05096780 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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