NCT06529055

Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Southern Mississippi · Academic / Other
• Sex: Male
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fatigue; Muscle, Heart
• Fatigue, Mental

Interventions

Type	Name	Description
OTHER	Oral Pouch - Nicotine	Ingestion of a randomized oral nicotine pouch
OTHER	Oral Pouch - Caffeine	Ingestion of a randomized oral caffeine pouch
OTHER	Oral Pouch - Placebo	Ingestion of a randomized oral placebo pouch

Timeline

• Start date: 2024-07-30
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-07-31
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States