Status:
ENROLLING_BY_INVITATION
Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior
Lead Sponsor:
University of Southern Mississippi
Conditions:
Fatigue; Muscle, Heart
Fatigue, Mental
Eligibility:
MALE
21-40 years
Phase:
NA
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06529055
Start Date
July 30 2024
End Date
December 31 2024
Last Update
August 2 2024
Active Locations (1)
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1
University of Southern Mississippi - School of Kinesiology and Nutrition
Hattiesburg, Mississippi, United States, 39406