Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Alertness, sponsored by PepsiCo Global R&D.
NCT05096780 is a Phase 1 study of Alertness that has completed, run by PepsiCo Global R&D. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A self-reported mood measurement from the Caffeine Research Visual Analog Scale (VAS) rated from 0 (not at all) to 100 mm (extremely alert), to compare dose-matched free caffeine to encapsulated caffeine. Longer-lasting alertness would be a benefit.
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 |
What the finished NCT05096780 record still lists
NCT05096780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alertness
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05096780's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01535430 · 75 participants
Assessment of Eloquent Function in Brain Tumor Patients
- NCT01542879 · 75 participants · Phase 1
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
- NCT02232191 · 75 participants · Phase 2
Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
- NCT02754544 · 75 participants · NA
Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI