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

N/AEnrolling By InvitationNCT06529055

University of Southern Mississippi20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Fatigue; Muscle, Heart Fatigue, Mental

Eligibility

Sex: MALEMin age: 21 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Wingate Anaerobic Cycling Test

Changes in anaerobic cycling power output

Time frame: 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

Time frame: Baseline, 25, 32 minutes post-ingestion

Concentration of salivary cortisol

Changes in salivary cortisol concentration from saliva

Time frame: Baseline, 15, 25, 32 minutes post-ingestion

Concentration of salivary interleukin-6

Changes in interleukin-6 concentration from saliva

Time frame: Baseline, 15, 25, 32 minutes post-ingestion

Salivary catecholamine concentration

Changes in salivary catecholamine concentration from saliva

Time frame: Baseline, 15, 27, 40 minutes post-ingestion

Profile of Mood States

Changes in Profile of Mood States scores (Score range: 0-60)

Time frame: Baseline, 15, 32 minutes post-ingestion

Balance

Changes in standing postural sway

Time frame: 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))

Time frame: 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

Time frame: Baseline, 15, 25, 32 minutes post-ingestion

Desire to eat - Visual Digital Analog Scale (0-100)

Changes in subjective ratings of desire to eat

Time frame: 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

Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion

Fullness - Visual Digital Analog Scale (0-100)

Changes in subjective ratings of fullness

Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion

Food Intake - Digital 24-hour food record

Consumption of food and beverage after study visit

Time frame: 24 hours following the end of each visit

Blood Pressure

Absolute brachial blood pressure values (systolic and diastolic) and relative changes from baseline.

Time frame: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion

Heart Rate

Absolute heart rate values and relative changes from baseline.

Time frame: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion

Trail Making Test - Digital Cognitive Function Test

Changes in trail making test scores

Time frame: Baseline, 15, 32 minutes post-ingestion

Sustained Attention Test - Digital Cognitive Function Test

Changes in sustained attention test scores

Time frame: Baseline, 15, 32 minutes post-ingestion

Visual Working Memory Span Test - Digital Cognitive Function Test

Changes in visual working memory span test scores

Time frame: Baseline, 15, 32 minutes post-ingestion

Stroop Test - Digital Cognitive Function Test

Changes in Stroop test scores

Time frame: Baseline, 15, 32 minutes post-ingestion

Deary-Liewald Test - Digital Cognitive Function Test

Changes in Deary-Liewald test scores

Time frame: Baseline, 15, 32 minutes post-ingestion

Cerebral Blood flow

Doppler ultrasound derived blood flow in the carotid artery

Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion

Secondary Outcomes

Blood Glucose Concentration

Changes in blood glucose concentration from capillary blood

Time frame: Baseline, 15, 25, 32 minutes post-ingestion

Salivary insulin concentration

Changes in salivary insulin concentration from saliva

Time frame: Baseline, 15, 25, and 32 minutes post-ingestion

Prefrontal Cortex Oxygenation

Near-infrared spectroscopy

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes