Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Eric Sikorski, PhD; Matthew Sharp, MS
Data sourced from clinicaltrials.gov
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