Fatigue, Mental, Fatigue; Muscle, Heart
Conditions
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.
Interventions
OTHEROral Pouch - Nicotine
Ingestion of a randomized oral nicotine pouch
OTHEROral Pouch - Caffeine
Ingestion of a randomized oral caffeine pouch
OTHEROral Pouch - Placebo
Ingestion of a randomized oral placebo pouch
Sponsors
University of Southern Mississippi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Blood flow | Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion | Doppler ultrasound derived blood flow in the carotid artery |
| Heart Rate | Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion | Absolute heart rate values and relative changes from baseline. |
| 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 |
| Stroop Test - Digital Cognitive Function Test | Baseline, 15, 32 minutes post-ingestion | Changes in Stroop test scores |
| Deary-Liewald Test - Digital Cognitive Function Test | Baseline, 15, 32 minutes post-ingestion | Changes in Deary-Liewald 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 |
| Concentration of blood lactate | Baseline, 25, 32 minutes post-ingestion | Changes in blood lactate concentration from capillary blood |
| Concentration of salivary cortisol | Baseline, 15, 25, 32 minutes post-ingestion | Changes in salivary cortisol concentration from saliva |
| 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 |
| 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 |
| 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)) |
| Hunger - Visual Digital Analog Scale (0-100) | Baseline, 15, 25, 32 minutes post-ingestion | Changes in subjective ratings of hunger |
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary insulin concentration | Baseline, 15, 25, and 32 minutes post-ingestion | Changes in salivary insulin concentration from saliva |
| Prefrontal Cortex Oxygenation | Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion | Near-infrared spectroscopy |
| 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) |
| 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) |
| Peripheral Blood Flow | Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion | Doppler ultrasound derived blood flow in the brachial artery |
| Blood Glucose Concentration | Baseline, 15, 25, 32 minutes post-ingestion | Changes in blood glucose concentration from capillary blood |
Countries
United States
Outcome results
None listed