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

NCT ID: NCT06529055

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2024-12-31

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.

Conditions

Fatigue; Muscle, Heart; Fatigue, Mental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Oral Nicotine Pouches

Single dose 3mg oral nicotine pouch

Group Type: EXPERIMENTAL

Oral Pouch - Nicotine

Intervention Type: OTHER

Ingestion of a randomized oral nicotine pouch

Oral Caffeine Pouches

Single dose 100mg oral caffeine pouch

Group Type: EXPERIMENTAL

Oral Pouch - Caffeine

Intervention Type: OTHER

Ingestion of a randomized oral caffeine pouch

Combination of oral nicotine and caffeine pouches

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

Group Type: EXPERIMENTAL

Oral Pouch - Nicotine

Intervention Type: OTHER

Ingestion of a randomized oral nicotine pouch

Oral Pouch - Caffeine

Intervention Type: OTHER

Ingestion of a randomized oral caffeine pouch

Placebo

Flavor, color, and appearance matched placebo

Group Type: PLACEBO_COMPARATOR

Oral Pouch - Placebo

Intervention Type: OTHER

Ingestion of a randomized oral placebo pouch

Interventions

Oral Pouch - Nicotine

Ingestion of a randomized oral nicotine pouch

Intervention Type: OTHER

Oral Pouch - Caffeine

Ingestion of a randomized oral caffeine pouch

Intervention Type: OTHER

Oral Pouch - Placebo

Ingestion of a randomized oral placebo pouch

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern Mississippi

OTHER

Sponsor Role: lead

Responsible Party

Austin Graybeal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Austin J Graybeal, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Mississippi

Locations

University of Southern Mississippi - School of Kinesiology and Nutrition

Hattiesburg, Mississippi, United States

Countries

United States

Other Identifiers

24-0285

Identifier Type: -

Identifier Source: org_study_id