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

University of Southern Mississippi

Status: Invitation-only

Conditions: Fatigue, Mental; Fatigue; Muscle, Heart

Treatments: Other: Oral Pouch - Placebo; Other: Oral Pouch - Nicotine; Other: Oral Pouch - Caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT06529055

24-0285

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

Oral Nicotine Pouches

Experimental group

Description:

Single dose 3mg oral nicotine pouch

Treatment:

Other: Oral Pouch - Nicotine

Oral Caffeine Pouches

Experimental group

Description:

Single dose 100mg oral caffeine pouch

Treatment:

Other: Oral Pouch - Caffeine

Combination of oral nicotine and caffeine pouches

Experimental group

Description:

Single simultaneous doses of a 3mg oral nicotine pouch and a 100mg oral caffeine pouch

Treatment:

Other: Oral Pouch - Caffeine

Other: Oral Pouch - Nicotine

Placebo

Placebo Comparator group

Description:

Flavor, color, and appearance matched placebo

Treatment:

Other: Oral Pouch - Placebo