Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441695
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-29
Brief Title:
Acute Effects of PLT Health Solutions zumXR Extended-Release Caffeine
Sponsor:
Applied Science Performance Institute
Organization:
Applied Science Performance Institute
Study Overview
Official Title:
The Acute Effects of PLT Health Solutions zumXR Extended-Release Caffeine on Side Effects Mood and Alertness Following a Night of Suboptimal Sleep
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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-screeningenrollment 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 521 inclusion criteria and 522 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-PerilliThayers 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
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-PerilliThayers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None