Effects of extended-release caffeine on mood and cognitive abilities after poor sleep
The Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine on Side Effects, Mood and Alertness Following a Night of Suboptimal Sleep
NA · Applied Science & Performance Institute · NCT06441695
This study tests if extended-release caffeine can improve mood and thinking skills better than regular caffeine in people who didn't get enough sleep.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 35 Years to 50 Years |
| Sex | All |
| Sponsor | Applied Science & Performance Institute (industry) |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06441695 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the impact of extended-release caffeine compared to immediate-release caffeine on mood states, alertness, and cognitive performance following a night of inadequate sleep. It employs a double-blind, randomized, crossover design with 36 healthy participants from the Tampa Bay Area, who will undergo two laboratory visits after a minimum 10-hour fast and a night of sleep deprivation. Participants will be assessed using various cognitive and mood evaluation tools to determine the efficacy and side effect profiles of the caffeine formulations.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 35-50 who are moderate caffeine consumers and have an intermediate chronotype.
Not a fit: Patients with a history of anxiety or sleep disorders, smokers, or those who consume alcohol or sleep medications prior to the study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how different caffeine formulations can enhance cognitive function and mood in individuals experiencing sleep deprivation.
How similar studies have performed: While there have been studies on caffeine effects, this specific approach comparing extended-release and immediate-release formulations in a sleep-deprived context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Tampa, Florida
- Applied Science & Performance Institute — Tampa, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Eric Sikorski, PhD
- Email: esikorski@theaspi.com
- Phone: 8138678888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Caffeine, Cognitive Change, Mood, Mood Change, extended release caffeine, caffeine