Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529055
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance Autonomic Function Cognition and Behavior
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance Autonomic Function Cognition and Behavior
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized placebo controlled crossover trial is to determine effects of oral nicotine and caffeine pouches on anaerobic performance autonomic function cognition and behavior in adult non-obese adult male volunteers between ages 21 and 40
Accordingly the primary aims of the study are to determine the effects of acute oral nicotine pouches oral caffeine pouches or both on measures of
anaerobic performance
cognition
cardiovascular and autonomic function
appetite and food intake
Researchers will compare oral nicotine pouches oral caffeine pouches both oral nicotine and caffeine pouches and a flavor and color matched placebo to see if how they differentially affect measurements of
physical performance
cognition
cardiovascular and autonomic function
appetite and food intake
On four separate occasions participants will be asked to place the oral pouches in their mouth and complete several anerobic cycling cognitive and balance tests while blood and salivary biomarkers subjective appetite ratings and cardiovascular and autonomic function measurements are collected After each trial participants will complete a 24-hr food record
Accordingly the primary aims of the study are to determine the effects of acute oral nicotine pouches oral caffeine pouches or both on measures of
anaerobic performance
cognition
cardiovascular and autonomic function
appetite and food intake
Researchers will compare oral nicotine pouches oral caffeine pouches both oral nicotine and caffeine pouches and a flavor and color matched placebo to see if how they differentially affect measurements of
physical performance
cognition
cardiovascular and autonomic function
appetite and food intake
On four separate occasions participants will be asked to place the oral pouches in their mouth and complete several anerobic cycling cognitive and balance tests while blood and salivary biomarkers subjective appetite ratings and cardiovascular and autonomic function measurements are collected After each trial participants will complete a 24-hr food record
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None