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

NCT06529055 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-02

No results posted yet for this study

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

Interventions

OTHER

Oral Pouch - Nicotine

Ingestion of a randomized oral nicotine pouch

OTHER

Oral Pouch - Caffeine

Ingestion of a randomized oral caffeine pouch

OTHER

Oral Pouch - Placebo

Ingestion of a randomized oral placebo pouch

Sponsors & Collaborators

  • University of Southern Mississippi

    lead OTHER

Principal Investigators

  • Austin J Graybeal, PhD · University of Southern Mississippi

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06529055 on ClinicalTrials.gov