Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior
- Conditions
- Fatigue; Muscle, HeartFatigue, Mental
- Interventions
- Other: Oral Pouch - CaffeineOther: Oral Pouch - NicotineOther: Oral Pouch - Placebo
- Registration Number
- NCT06529055
- Lead Sponsor
- University of Southern Mississippi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Male
- Target Recruitment
- 20
- Being 21 to 40 years of age
- Being biologically male
- Having a body mass index (BMI) of < 30 kilograms/meter-squared
- Participating in moderate/vigorous exercise for at least 150 minutes/week over the last month
- individuals who are younger than 21 or older than 40
- missing any limbs or part of a limb
- having any neuromuscular/musculoskeletal injury or impairment that would prevent performing any exercise/functional measures for this study
- having a pacemaker or any other electrical implant
- a diagnosis (defined as the presence of disease of or using medication to treat the disease) of heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease, type I or type II diabetes
- taking insulin injections
- any history of severe or mild traumatic brain injury within the last two years
- kidney, liver, thyroid, or heart disease
- treated or untreated American Heart Association stage 2 hypertension (>140 millimeters of mercury / > 90 millimeters of mercury)
- any diagnosed neurological or neurodegenerative diseases
- having donated blood or plasma in the last 20 days prior to blood collection procedures
- taking any supplements/medications that may interfere with the results of the study
- any surgeries that would impact swallowing and/or digestion
- currently smoking, vaping, using e-cigarettes, or using any other combustible/smokeless tobacco products
- using smokeless tobacco-free nicotine products on more than 2 days/week
- daily caffeine use of more than 250 milligrams/day or use of any oral caffeine pouches
- have allergies or are regularly taking medications that would impact this study and/or negatively interact with caffeine or nicotine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oral Caffeine Pouches Oral Pouch - Caffeine Single dose 100mg oral caffeine pouch Combination of oral nicotine and caffeine pouches Oral Pouch - Caffeine Single simultaneous doses of a 3mg oral nicotine pouch and a 100mg oral caffeine pouch Oral Nicotine Pouches Oral Pouch - Nicotine Single dose 3mg oral nicotine pouch Combination of oral nicotine and caffeine pouches Oral Pouch - Nicotine Single simultaneous doses of a 3mg oral nicotine pouch and a 100mg oral caffeine pouch Placebo Oral Pouch - Placebo Flavor, color, and appearance matched placebo
- Primary Outcome Measures
Name Time Method Heart Rate Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion Absolute heart rate values and relative changes from baseline.
Concentration of blood lactate Baseline, 25, 32 minutes post-ingestion Changes in blood lactate concentration from capillary blood
Concentration of salivary interleukin-6 Baseline, 15, 25, 32 minutes post-ingestion Changes in interleukin-6 concentration from saliva
Salivary catecholamine concentration Baseline, 15, 27, 40 minutes post-ingestion Changes in salivary catecholamine concentration from saliva
Ratings of perceived exertion Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion Changes in ratings of perceived exertion (Scale range: 6-20 - lower ratings means less effort))
Cerebral Blood flow Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion Doppler ultrasound derived blood flow in the carotid artery
Concentration of salivary cortisol Baseline, 15, 25, 32 minutes post-ingestion Changes in salivary cortisol concentration from saliva
Desire to eat - Visual Digital Analog Scale (0-100) Baseline, 15, 25, 32, 60 minutes post-ingestion Changes in subjective ratings of desire to eat
Hunger - Visual Digital Analog Scale (0-100) Baseline, 15, 25, 32 minutes post-ingestion Changes in subjective ratings of hunger
Trail Making Test - Digital Cognitive Function Test Baseline, 15, 32 minutes post-ingestion Changes in trail making test scores
Sustained Attention Test - Digital Cognitive Function Test Baseline, 15, 32 minutes post-ingestion Changes in sustained attention test scores
Visual Working Memory Span Test - Digital Cognitive Function Test Baseline, 15, 32 minutes post-ingestion Changes in visual working memory span test scores
Wingate Anaerobic Cycling Test Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion Changes in anaerobic cycling power output
Profile of Mood States Baseline, 15, 32 minutes post-ingestion Changes in Profile of Mood States scores (Score range: 0-60)
Balance Baseline, 15, 32 minutes post-ingestion Changes in standing postural sway
Stroop Test - Digital Cognitive Function Test Baseline, 15, 32 minutes post-ingestion Changes in Stroop test scores
Prospective Consumption of Food - Visual Digital Analog Scale (0-100) Baseline, 15, 25, 32, 60 minutes post-ingestion Changes in subjective ratings of prospective consumption of food
Fullness - Visual Digital Analog Scale (0-100) Baseline, 15, 25, 32, 60 minutes post-ingestion Changes in subjective ratings of fullness
Food Intake - Digital 24-hour food record 24 hours following the end of each visit Consumption of food and beverage after study visit
Blood Pressure Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion Absolute brachial blood pressure values (systolic and diastolic) and relative changes from baseline.
Deary-Liewald Test - Digital Cognitive Function Test Baseline, 15, 32 minutes post-ingestion Changes in Deary-Liewald test scores
- Secondary Outcome Measures
Name Time Method Prefrontal Cortex Oxygenation Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion Near-infrared spectroscopy
Blood Glucose Concentration Baseline, 15, 25, 32 minutes post-ingestion Changes in blood glucose concentration from capillary blood
Salivary insulin concentration Baseline, 15, 25, and 32 minutes post-ingestion Changes in salivary insulin concentration from saliva
Peripheral Vascular Conductance Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion Blood flow in the brachial artery normalized to blood pressure (mL/min/mmHg)
Peripheral Blood Flow Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion Doppler ultrasound derived blood flow in the brachial artery
Electromyography Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, and 32 minutes post-ingestion Electromyographic reading of muscle activity of the active muscles (glutes, hamstrings, quadriceps, and calves)
Trial Locations
- Locations (1)
University of Southern Mississippi - School of Kinesiology and Nutrition
🇺🇸Hattiesburg, Mississippi, United States