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

NCT06529055 | Enrolling By Invitation

• 1 other identifier: 24-0285
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (21)

• Wingate Anaerobic Cycling Test

  Changes in anaerobic cycling power output

  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

  Baseline, 25, 32 minutes post-ingestion

• Concentration of salivary cortisol

  Changes in salivary cortisol concentration from saliva

  Baseline, 15, 25, 32 minutes post-ingestion

• Concentration of salivary interleukin-6

  Changes in interleukin-6 concentration from saliva

  Baseline, 15, 25, 32 minutes post-ingestion

• Salivary catecholamine concentration

  Changes in salivary catecholamine concentration from saliva

  Baseline, 15, 27, 40 minutes post-ingestion

• Profile of Mood States

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

  Baseline, 15, 32 minutes post-ingestion

• Balance

  Changes in standing postural sway

  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))

  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

  Baseline, 15, 25, 32 minutes post-ingestion

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

  Changes in subjective ratings of desire to eat

  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

  Baseline, 15, 25, 32, 60 minutes post-ingestion

• Fullness - Visual Digital Analog Scale (0-100)

  Changes in subjective ratings of fullness

  Baseline, 15, 25, 32, 60 minutes post-ingestion

• Food Intake - Digital 24-hour food record

  Consumption of food and beverage after study visit

  24 hours following the end of each visit

• Blood Pressure

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

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

• Heart Rate

  Absolute heart rate values and relative changes from baseline.

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

• Trail Making Test - Digital Cognitive Function Test

  Changes in trail making test scores

  Baseline, 15, 32 minutes post-ingestion

• Sustained Attention Test - Digital Cognitive Function Test

  Changes in sustained attention test scores

  Baseline, 15, 32 minutes post-ingestion

• Visual Working Memory Span Test - Digital Cognitive Function Test

  Changes in visual working memory span test scores

  Baseline, 15, 32 minutes post-ingestion

• Stroop Test - Digital Cognitive Function Test

  Changes in Stroop test scores

  Baseline, 15, 32 minutes post-ingestion

• Deary-Liewald Test - Digital Cognitive Function Test

  Changes in Deary-Liewald test scores

  Baseline, 15, 32 minutes post-ingestion

• Cerebral Blood flow

  Doppler ultrasound derived blood flow in the carotid artery

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

Secondary Outcomes (6)

• Blood Glucose Concentration

  Baseline, 15, 25, 32 minutes post-ingestion

• Salivary insulin concentration

  Baseline, 15, 25, and 32 minutes post-ingestion

• Prefrontal Cortex Oxygenation

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

• Peripheral Vascular Conductance

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

• Electromyography

  Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, and 32 minutes post-ingestion

Study Arms (4)

Oral Nicotine Pouches

EXPERIMENTAL

Single dose 3mg oral nicotine pouch

Other: Oral Pouch - Nicotine

Oral Caffeine Pouches

EXPERIMENTAL

Single dose 100mg oral caffeine pouch

Other: Oral Pouch - Caffeine

Combination of oral nicotine and caffeine pouches

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

Flavor, color, and appearance matched placebo

Other: Oral Pouch - Placebo

Interventions

Oral Pouch - Nicotine OTHER

Ingestion of a randomized oral nicotine pouch

Combination of oral nicotine and caffeine pouches; Oral Nicotine Pouches

Oral Pouch - Caffeine OTHER

Ingestion of a randomized oral caffeine pouch

Combination of oral nicotine and caffeine pouches; Oral Caffeine Pouches

Oral Pouch - Placebo OTHER

Ingestion of a randomized oral placebo pouch

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Mississippi: lead

Study Sites (1)

University of Southern Mississippi - School of Kinesiology and Nutrition

Hattiesburg, Mississippi, 39406, United States

Location

MeSH Terms

Conditions

Fatigue; Mental Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Austin J Graybeal, PhD

  University of Southern Mississippi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 31, 2024
• Study Start: July 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)