CaffeineNCT06441695
Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine
A study testing xumXR extended release caffeine and immediate release caffeine in people with Caffeine and Cognitive Change, run by Applied Science & Performance Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Cognitive Change, Mood
- What is being tested?
- xumXR extended release caffeine and immediate release caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 35-50 years (both limits inclusive);
- Body mass index (BMI) of 18.50-29.99 kg/m2 -Habitual moderate caffeine consumers (200-400 mg/day) assessed through caffeine assessment tool (Caffeine -
- Consumption Questionnaire, CCQ);
- Intermediate chronotype (>31 or <69 on Morningness-Eveningness Questionnaire).
Who cannot join
- Subjects presenting any of the following will not be included in the study:
- No history of anxiety disorders or sleep disorders;
- Non-smokers;
- Alcohol consumption 72 hours prior to the start of study/consumption of study product;
- No use of sleep medicines, melatonin, marijuana within two weeks of start of study;
- No travel involving time zone change, shift work, or other life events that alter sleep schedule >3 hours from the norm one week before the start of study (assessed using sleep-wake schedule diary for week prior to study);
- Caffeine restricted past 12 PM from the day prior to the start of study (verify through caffeine diet history).
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Science & Performance Institute
Tampa, Florida, 33634
About this study
Official title: The Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine on Side Effects, Mood and Alertness Following a Night of Suboptimal Sleep
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.
Read the detailed description
Pre-screening/enrollment (Day -30 to Day -1) The potential subject will present a health history / Caffeine Consumption / Morningness-Eveningness questionnaires to screen for study eligibility described in sections 5.2.1 (inclusion criteria) and 5.2.2 (exclusion criteria). The questionnaires will be reviewed by the Investigator or designee. If the subject is eligible, they will be contacted by phone to walk through the study requirements and answer any questions. If the subject qualifies and is amenable with the study requirements, we will obtain written consent via an IRB approved ICF. The potential subject will be given the opportunity to review the ICF, ask any questions they may have to the Investigator or designee. The potential subject will be required to sign the ICF for study enrollment and to proceed with study participation.
Baseline assessment (Day 0, Visit 1) 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 (Roberts et al., 2020). Upon arrival, participants will undergo baseline (BL) testing (Heart rate, blood pressure, Caffeine VAS, Samn-Perilli/Thayer's, PANAS, PVT, RVIP). Immediately after, subjects will ingest a bolus of one study product (either ER-CAFF or IR-CAFF) with 4-8 ounces of water: 400 mg zümXR extended-release caffeine (ER-CAFF), or 400 mg of immediate-release caffeine (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. This testing will include the vitals listed above, a subset of the BL tests according to the time point (see below, Table 2), and queried about adverse events. At the 4-hour (240 min) measurement, a standardized caffeine-free food bar will be provided. This food bar will also be offered to participants following the final 7-hour (420 min) measurements. After the completion of Day 0, There will be a one-week minimum washout period between treatments in the crossover design.
Final Testing (Day 1, Visit 2):
After the one-week minimum washout period, subjects will report back to the lab and will repeat Day 0 testing with the other supplement (either ER-CAFF or IR-CAFF). Following this testing, the subjects will have completed the study.
- Conditions
- Caffeine, Cognitive Change, Mood, Mood Change
- Being tested
- xumXR extended release caffeine, immediate release caffeine
- Keywords
- extended release caffeine, caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xumXR extended release caffeineDietary supplement
proprietary capsule for extended release of caffeine
immediate release caffeineDietary supplement
immediate release caffeine capsule
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | extended release xumXR caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg Receives: Dietary Supplement: xumXR extended release caffeine |
| Control Treatment | Active comparator | immediate release caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg Receives: Dietary Supplement: immediate release caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Concentration using Visual Analog Scale (VAS)
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.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Energy using Visual Analog Scale (VAS)
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 energy and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Confidence using Visual Analog Scale (VAS)
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 energy and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Mood Enhancement using Visual Analog Scale (VAS)
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 mood enhancements and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Jitteriness using Visual Analog Scale (VAS)
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). Lower values indicate less jitters and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Anxiousness using Visual Analog Scale (VAS)
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). Lower values indicate less jitters and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Sleepy using Visual Analog Scale (VAS)
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). Lower values indicate less jitters and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Irritability using Visual Analog Scale (VAS)
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). Lower values indicate less jitters and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Heart Rate (Heart Pounding) using Visual Analog Scale (VAS)
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). Lower values indicate less jitters and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Changes in Headache using Visual Analog Scale (VAS)
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). Lower values indicate less jitters and is considered to be a better outcome.
Measured: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Heart rate (HR)
Changes in heart rate post supplementation; resting HR measured using pulse oximeter
Measured: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
Diastolic blood pressure (BP)
Changes in diastolic BP post supplementation. Resting blood pressure measured using an automated BP cuff.
Measured: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
Systolic blood pressure (BP)
Changes in systolic BP post supplementation. Resting blood pressure measured using an automated BP cuff.
Measured: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
Secondary outcomes (4)
Changes in Rapid Visual Information Processing
This 12 minute test checks how well you can quickly spot specific patterns on a screen, helping measure your attention and focus. A participant is presented with a series of digits (1-9) on a computer screen. The presentation time is 100 digits/min (or 1digit/600ms). The participant's task is to press a response key (here: Spacebar) as soon as she detects a series of three consecutive odd or three consecutive even digits.
Measured: baseline , 90 and 300 minutes post-supplementation.
Changes in Psychomotor Vigilance Test
This test measures how quickly and accurately you can respond to simple tasks, like pressing a button when you see a specific symbol. It assesses your reaction time and attention span. Participants are instructed to press the <Spacebar> as fast as possible after a red stopwatch appears on screen. A valid response (response occurs after a stopwatch appears) is followed by reaction time feedback.
Measured: baseline , 90 and 300 minutes post-supplementation.
Changes in Samn-Perelli/Thayer's scale (aka Stanford Sleepiness Scale)
This subjective assessment tool will be used to measure the subject's perceived level of sleepiness or alertness. This tool consists of seven statements or descriptions, each corresponding to a different level of sleepiness or alertness. Respondents are asked to select the statement that best describes their current level of alertness. The scale ranges from 1 to 7, with 1 indicating the highest level of alertness (feeling active, vital, alert, or wide awake) and 7 indicating the lowest level of alertness (no longer fighting sleep, sleep onset soon, having dream-like thoughts).
Measured: baseline, 90, 300, and 420 minutes post-supplementation.
Changes in Positive & Negative Affect Schedule (PANAS)
This scale consists of a number of words that describe different feelings and emotions. Subject will choose a number 1 through 5 (1=Very slightly or not at all, 5=extremely) to describe the feeling/emotion listed. Overall positive and negative scores will be tallied for interpretation.
Measured: baseline, 90, 300, and 420 minutes post-supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start13 Jun 2024
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441695
- Sponsor's protocol ID
- Pro00078903
- Status last verified
- Sep 2025
- First submitted
- 29 May 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine on Side Effects, Mood and Alertness Following a Night of Suboptimal Sleep
- ClinicalTrials.gov ID
- NCT06441695
- Acronym / sponsor ID
- Pro00078903
- Conditions
- Caffeine, Cognitive Change, Mood, Mood Change
- Keywords
- extended release caffeine, caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pre-screening/enrollment (Day -30 to Day -1) The potential subject will present a health history / Caffeine Consumption / Morningness-Eveningness questionnaires to screen for study eligibility described in sections 5.2.1 (inclusion criteria) and 5.2.2 (exclusion criteria). The questionnaires will be reviewed by the Investigator or designee. If the subject is eligible, they will be contacted by phone to walk through the study requirements and answer any questions. If the subject qualifies and is amenable with the study requirements, we will obtain written consent via an IRB approved ICF. The potential subject will be given the opportunity to review the ICF, ask any questions they may have to the Investigator or designee. The potential subject will be required to sign the ICF for study enrollment and to proceed with study participation.
Baseline assessment (Day 0, Visit 1) 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 (Roberts et al., 2020). Upon arrival, participants will undergo baseline (BL) testing (Heart rate, blood pressure, Caffeine VAS, Samn-Perilli/Thayer's, PANAS, PVT, RVIP). Immediately after, subjects will ingest a bolus of one study product (either ER-CAFF or IR-CAFF) with 4-8 ounces of water: 400 mg zümXR extended-release caffeine (ER-CAFF), or 400 mg of immediate-release caffeine (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. This testing will include the vitals listed above, a subset of the BL tests according to the time point (see below, Table 2), and queried about adverse events. At the 4-hour (240 min) measurement, a standardized caffeine-free food bar will be provided. This food bar will also be offered to participants following the final 7-hour (420 min) measurements. After the completion of Day 0, There will be a one-week minimum washout period between treatments in the crossover design.
Final Testing (Day 1, Visit 2):
After the one-week minimum washout period, subjects will report back to the lab and will repeat Day 0 testing with the other supplement (either ER-CAFF or IR-CAFF). Following this testing, the subjects will have completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Dietary Supplement: xumXR extended release caffeineextended release xumXR caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg |
| Control Treatment | Active comparator | Dietary Supplement: immediate release caffeineimmediate release caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female aged 35-50 years (both limits inclusive);
- Body mass index (BMI) of 18.50-29.99 kg/m2 -Habitual moderate caffeine consumers (200-400 mg/day) assessed through caffeine assessment tool (Caffeine -
- Consumption Questionnaire, CCQ);
- Intermediate chronotype (>31 or <69 on Morningness-Eveningness Questionnaire).
Key exclusion criteria (7 listed)
- Subjects presenting any of the following will not be included in the study:
- No history of anxiety disorders or sleep disorders;
- Non-smokers;
- Alcohol consumption 72 hours prior to the start of study/consumption of study product;
- No use of sleep medicines, melatonin, marijuana within two weeks of start of study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xumXR extended release caffeineproprietary capsule for extended release of caffeine | Dietary supplement | Experimental Treatment |
| immediate release caffeineimmediate release caffeine capsule | Dietary supplement | Control Treatment |
Primary outcome
Changes in Concentration using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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.
Changes in Energy using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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 energy and is considered to be a better outcome.
Changes in Confidence using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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 energy and is considered to be a better outcome.
Changes in Mood Enhancement using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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 mood enhancements and is considered to be a better outcome.
Changes in Jitteriness using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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). Lower values indicate less jitters and is considered to be a better outcome.
Changes in Anxiousness using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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). Lower values indicate less jitters and is considered to be a better outcome.
Changes in Sleepy using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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). Lower values indicate less jitters and is considered to be a better outcome.
Changes in Irritability using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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). Lower values indicate less jitters and is considered to be a better outcome.
Changes in Heart Rate (Heart Pounding) using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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). Lower values indicate less jitters and is considered to be a better outcome.
Changes in Headache using Visual Analog Scale (VAS)
Time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
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). Lower values indicate less jitters and is considered to be a better outcome.
Heart rate (HR)
Time frame: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
Changes in heart rate post supplementation; resting HR measured using pulse oximeter
Diastolic blood pressure (BP)
Time frame: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
Changes in diastolic BP post supplementation. Resting blood pressure measured using an automated BP cuff.
Systolic blood pressure (BP)
Time frame: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
Changes in systolic BP post supplementation. Resting blood pressure measured using an automated BP cuff.
4 secondary outcomes
Changes in Rapid Visual Information Processing
Time frame: baseline , 90 and 300 minutes post-supplementation.
Changes in Psychomotor Vigilance Test
Time frame: baseline , 90 and 300 minutes post-supplementation.
Changes in Samn-Perelli/Thayer's scale (aka Stanford Sleepiness Scale)
Time frame: baseline, 90, 300, and 420 minutes post-supplementation.
Changes in Positive & Negative Affect Schedule (PANAS)
Time frame: baseline, 90, 300, and 420 minutes post-supplementation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xumXR extended release caffeine and immediate release caffeine in people with Caffeine and Cognitive Change, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Concentration using Visual Analog Scale (VAS) (time frame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.