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NCT06441695 · ClinicalTrials.gov registry record · NA
Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine
A NA study, sponsored by Applied Science & Performance Institute.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT06441695: Completed NA study, sponsored by Applied Science & Performance Institute.
NCT06441695 is a NA study that has completed, run by Applied Science & Performance Institute. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06441695, a NA study, has completed, sponsored by Applied Science & Performance Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
This will be a (2 visit) double-blind, randomized, crossover design clinical study to assess the potential benefits of ER-CAFF versus IR-CAFF by assessing its impact on side effect profiles, mood states, alertness, and cognitive abilities following ingestion after a suboptimal night of sleep. This study will enroll 30 healthy men and women who will be recruited by word of mouth, email contact, and direct contact from the greater Tampa Bay Area. To account for potential dropouts, we aim to enroll approximately 20% over the desired sample size (total of 36 participants). The anticipated study period will last approximately 2 weeks. After initial pre-screening, participants will report to the laboratory on two separate occasions after an overnight fast (10 hours minimum). Participants will be required to have a night of partial sleep deprivation the night before (\<5 hours sleep), which will be confirmed by self reported sleep logs and objective multisensor (triaxial accelerometry and cardiac data) wearable devices to accurately measure sleep deficit data. Upon arrival, participants will undergo baseline (BL) testing and then ingest a bolus of one study product with 4-8 ounces of water: 400 mg zümXR extended-release caffeine (ER-CAFF), or 400 mg of immediate-release caffeine anhydrous (IR-CAFF) (2 group, crossover design). Thereafter, participants will undergo subsequent testing sessions at 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. After the 4-hour (240 min) measurements, a caffeine-free food bar will be provided. This same food bar will also be offered to participants following the final 7-hour (420 min) measurements. The precise measures and timepoints for the measures are further defined below. There will be a one-week minimum washout period between treatments in the crossover design.
Primary Outcome
The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Higher values indicate greater alertness and is considered to be a better outcome.
Interventions
- DIETARY_SUPPLEMENT xumXR extended release caffeine
- DIETARY_SUPPLEMENT immediate release caffeine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-06-13 |
| Est. Completion | 2024-10-25 |
| Phase | NA |
What the finished NCT06441695 record still lists
NCT06441695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which xumXR extended release caffeine is the first listed.
NCT06441695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06441695 about?
NCT06441695 is a clinical study titled "Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine". This will be a (2 visit) double-blind, randomized, crossover design clinical study to assess the potential benefits of ER-CAFF versus IR-CAFF by assessing its impact on side effect profiles, mood states, alertness, and cognitive abilities following ingestion after a suboptimal night of sleep. This s...
What is the current status of trial NCT06441695?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2024-06-13. Estimated completion is 2024-10-25.
What interventions are being tested in trial NCT06441695?
The interventions under investigation include: xumXR extended release caffeine (DIETARY_SUPPLEMENT), immediate release caffeine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06441695?
This trial is sponsored by Applied Science & Performance Institute, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06441695's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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