Clinical trial NCT06529055: Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior
Official title: Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Fatigue; Muscle, Heart
Fatigue, Mental
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 20
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Wingate Anaerobic Cycling Test
timeFrame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
measure: Concentration of blood lactate
timeFrame: Baseline, 25, 32 minutes post-ingestion
measure: Concentration of salivary cortisol
timeFrame: Baseline, 15, 25, 32 minutes post-ingestion
measure: Concentration of salivary interleukin-6
timeFrame: Baseline, 15, 25, 32 minutes post-ingestion
measure: Salivary catecholamine concentration
timeFrame: Baseline, 15, 27, 40 minutes post-ingestion
measure: Profile of Mood States
timeFrame: Baseline, 15, 32 minutes post-ingestion
measure: Balance
timeFrame: Baseline, 15, 32 minutes post-ingestion
measure: Ratings of perceived exertion
timeFrame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
measure: Hunger - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 15, 25, 32 minutes post-ingestion
measure: Desire to eat - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 15, 25, 32, 60 minutes post-ingestion
measure: Prospective Consumption of Food - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 15, 25, 32, 60 minutes post-ingestion
measure: Fullness - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 15, 25, 32, 60 minutes post-ingestion
measure: Food Intake - Digital 24-hour food record
timeFrame: 24 hours following the end of each visit
measure: Blood Pressure
timeFrame: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
measure: Heart Rate
timeFrame: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
measure: Trail Making Test - Digital Cognitive Function Test
timeFrame: Baseline, 15, 32 minutes post-ingestion
measure: Sustained Attention Test - Digital Cognitive Function Test
timeFrame: Baseline, 15, 32 minutes post-ingestion
measure: Visual Working Memory Span Test - Digital Cognitive Function Test
timeFrame: Baseline, 15, 32 minutes post-ingestion
measure: Stroop Test - Digital Cognitive Function Test
timeFrame: Baseline, 15, 32 minutes post-ingestion
measure: Deary-Liewald Test - Digital Cognitive Function Test
timeFrame: Baseline, 15, 32 minutes post-ingestion
measure: Cerebral Blood flow
timeFrame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Secondary outcomes:
measure: Blood Glucose Concentration
timeFrame: Baseline, 15, 25, 32 minutes post-ingestion
measure: Salivary insulin concentration
timeFrame: Baseline, 15, 25, and 32 minutes post-ingestion
measure: Prefrontal Cortex Oxygenation
timeFrame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
measure: Peripheral Vascular Conductance
timeFrame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
measure: Electromyography
timeFrame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, and 32 minutes post-ingestion
measure: Peripheral Blood Flow
timeFrame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: University of Southern Mississippi - School of Kinesiology and Nutrition
state: Mississippi
Study officials:
affiliation: University of Southern Mississippi
name: Austin J Graybeal, PhD
role: PRINCIPAL_INVESTIGATOR
References: