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NCT04281758 · ClinicalTrials.gov registry record · Phase 1
Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers
A Phase 1 study of Plasma Caffeine Concentration, sponsored by PepsiCo Global R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04281758: Completed Phase 1 study of Plasma Caffeine Concentration, sponsored by PepsiCo Global R&D.
NCT04281758 is a Phase 1 study of Plasma Caffeine Concentration that has completed, run by PepsiCo Global R&D. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04281758, a Phase 1 study of Plasma Caffeine Concentration, has completed, sponsored by PepsiCo Global R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Plasma caffeine level
Conditions Studied
Interventions
- OTHER Beverage
Study Locations (1)
Minnesota
- Prism Clinical Research - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2020-10-13 |
| Phase | Phase 1 |
What the finished NCT04281758 record still lists
NCT04281758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Plasma Caffeine Concentration appearing as the primary indexed condition, and to 1 intervention - of which Beverage is the first listed.
NCT04281758 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04281758 about?
NCT04281758 is a clinical study titled "Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers". 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 heal...
What is the current status of trial NCT04281758?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-07-20. Estimated completion is 2020-10-13.
What conditions does trial NCT04281758 study?
This clinical trial studies the following conditions: Plasma Caffeine Concentration.
What interventions are being tested in trial NCT04281758?
The interventions under investigation include: Beverage (OTHER).
Who is sponsoring clinical trial NCT04281758?
This trial is sponsored by PepsiCo Global R&D, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04281758 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04281758's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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