Clinical trial NCT06441695: Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caffeine
Cognitive Change
Mood
Mood Change
Keywords: extended release caffeine
caffeine
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Changes in Concentration using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Energy using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Confidence using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Mood Enhancement using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Jitteriness using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Anxiousness using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Sleepy using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Irritability using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Heart Rate (Heart Pounding) using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Changes in Headache using Visual Analog Scale (VAS)
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
measure: Heart rate (HR)
timeFrame: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
measure: Diastolic blood pressure (BP)
timeFrame: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
measure: Systolic blood pressure (BP)
timeFrame: baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation
Secondary outcomes:
measure: Changes in Rapid Visual Information Processing
timeFrame: baseline , 90 and 300 minutes post-supplementation.
measure: Changes in Psychomotor Vigilance Test
timeFrame: baseline , 90 and 300 minutes post-supplementation.
measure: Changes in Samn-Perelli/Thayer's scale (aka Stanford Sleepiness Scale)
timeFrame: baseline, 90, 300, and 420 minutes post-supplementation.
measure: Changes in Positive & Negative Affect Schedule (PANAS)
timeFrame: baseline, 90, 300, and 420 minutes post-supplementation.
Other outcomes:
measure: Adverse Events
timeFrame: baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Locations:
city: Tampa
country: United States
facility: Applied Science & Performance Institute
state: Florida
Study officials:
References: