Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior
NCT Number: NCT06529055
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fatigue; Muscle, Heart|Fatigue, Mental
Interventions: OTHER: Oral Pouch - Nicotine|OTHER: Oral Pouch - Caffeine|OTHER: Oral Pouch - Placebo
Sponsor: University of Southern Mississippi
Sex: MALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-30
Completion Date: 2024-12-31
Locations: University of Southern Mississippi - School of Kinesiology and Nutrition, Hattiesburg, Mississippi, 39406, United States

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.

Primary Outcome Measures: Wingate Anaerobic Cycling Test, Changes in anaerobic cycling power output, Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion|Concentration of blood lactate, Changes in blood lactate concentration from capillary blood, Baseline, 25, 32 minutes post-ingestion|Concentration of salivary cortisol, Changes in salivary cortisol concentration from saliva, Baseline, 15, 25, 32 minutes post-ingestion|Concentration of salivary interleukin-6, Changes in interleukin-6 concentration from saliva, Baseline, 15, 25, 32 minutes post-ingestion|Salivary catecholamine concentration, Changes in salivary catecholamine concentration from saliva, Baseline, 15, 27, 40 minutes post-ingestion|Profile of Mood States, Changes in Profile of Mood States scores (Score range: 0-60), Baseline, 15, 32 minutes post-ingestion|Balance, Changes in standing postural sway, Baseline, 15, 32 minutes post-ingestion|Ratings of perceived exertion, Changes in ratings of perceived exertion (Scale range: 6-20 - lower ratings means less effort)), Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion|Hunger - Visual Digital Analog Scale (0-100), Changes in subjective ratings of hunger, Baseline, 15, 25, 32 minutes post-ingestion|Desire to eat - Visual Digital Analog Scale (0-100), Changes in subjective ratings of desire to eat, Baseline, 15, 25, 32, 60 minutes post-ingestion|Prospective Consumption of Food - Visual Digital Analog Scale (0-100), Changes in subjective ratings of prospective consumption of food, Baseline, 15, 25, 32, 60 minutes post-ingestion|Fullness - Visual Digital Analog Scale (0-100), Changes in subjective ratings of fullness, Baseline, 15, 25, 32, 60 minutes post-ingestion|Food Intake - Digital 24-hour food record, Consumption of food and beverage after study visit, 24 hours following the end of each visit|Blood Pressure, Absolute brachial blood pressure values (systolic and diastolic) and relative changes from baseline., Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion|Heart Rate, Absolute heart rate values and relative changes from baseline., Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion|Trail Making Test - Digital Cognitive Function Test, Changes in trail making test scores, Baseline, 15, 32 minutes post-ingestion|Sustained Attention Test - Digital Cognitive Function Test, Changes in sustained attention test scores, Baseline, 15, 32 minutes post-ingestion|Visual Working Memory Span Test - Digital Cognitive Function Test, Changes in visual working memory span test scores, Baseline, 15, 32 minutes post-ingestion|Stroop Test - Digital Cognitive Function Test, Changes in Stroop test scores, Baseline, 15, 32 minutes post-ingestion|Deary-Liewald Test - Digital Cognitive Function Test, Changes in Deary-Liewald test scores, Baseline, 15, 32 minutes post-ingestion|Cerebral Blood flow, Doppler ultrasound derived blood flow in the carotid artery, Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Secondary Outcome Measures: Blood Glucose Concentration, Changes in blood glucose concentration from capillary blood, Baseline, 15, 25, 32 minutes post-ingestion|Salivary insulin concentration, Changes in salivary insulin concentration from saliva, Baseline, 15, 25, and 32 minutes post-ingestion|Prefrontal Cortex Oxygenation, Near-infrared spectroscopy, Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion|Peripheral Vascular Conductance, Blood flow in the brachial artery normalized to blood pressure (mL/min/mmHg), Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion|Electromyography, Electromyographic reading of muscle activity of the active muscles (glutes, hamstrings, quadriceps, and calves), Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, and 32 minutes post-ingestion|Peripheral Blood Flow, Doppler ultrasound derived blood flow in the brachial artery, Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion