Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04281758
The ClinicalTrials.gov registry entry for NCT04281758 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 Plasma Caffeine Concentration appearing as the primary indexed condition, and to 1 intervention - of which Beverage is the first listed.
NCT04281758 reports 1 study location spanning 1 distinct geographic area - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.