This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
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.
The Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine on Side Effects, Mood and Alertness Following a Night of Suboptimal Sleep
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
| Inclusion Criteria | Exclusion Criteria |
|---|---|
|
|
Sponsor: Applied Science & Performance Institute
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.