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Enrolling by Invitation

NCT Number: NCT06529055

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

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.

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Key information

Age range

21 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Mississippi - School of Kinesiology and Nutrition

Hattiesburg, Mississippi, 39406, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Pouch - Nicotine

Other

Ingestion of a randomized oral nicotine pouch

Oral Pouch - Caffeine

Other

Ingestion of a randomized oral caffeine pouch

Oral Pouch - Placebo

Other

Ingestion of a randomized oral placebo pouch

Primary outcomes

  1. Wingate Anaerobic Cycling Test

    Time frame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion

    Changes in anaerobic cycling power output

  2. Concentration of blood lactate

    Time frame: Baseline, 25, 32 minutes post-ingestion

    Changes in blood lactate concentration from capillary blood

  3. Concentration of salivary cortisol

    Time frame: Baseline, 15, 25, 32 minutes post-ingestion

    Changes in salivary cortisol concentration from saliva

  4. Concentration of salivary interleukin-6

    Time frame: Baseline, 15, 25, 32 minutes post-ingestion

    Changes in interleukin-6 concentration from saliva

  5. Salivary catecholamine concentration

    Time frame: Baseline, 15, 27, 40 minutes post-ingestion

    Changes in salivary catecholamine concentration from saliva

  6. Profile of Mood States

    Time frame: Baseline, 15, 32 minutes post-ingestion

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

  7. Balance

    Time frame: Baseline, 15, 32 minutes post-ingestion

    Changes in standing postural sway

  8. Ratings of perceived exertion

    Time frame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion

    Changes in ratings of perceived exertion (Scale range: 6-20 - lower ratings means less effort))

  9. Hunger - Visual Digital Analog Scale (0-100)

    Time frame: Baseline, 15, 25, 32 minutes post-ingestion

    Changes in subjective ratings of hunger

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

    Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion

    Changes in subjective ratings of desire to eat

  11. Prospective Consumption of Food - Visual Digital Analog Scale (0-100)

    Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion

    Changes in subjective ratings of prospective consumption of food

  12. Fullness - Visual Digital Analog Scale (0-100)

    Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion

    Changes in subjective ratings of fullness

  13. Food Intake - Digital 24-hour food record

    Time frame: 24 hours following the end of each visit

    Consumption of food and beverage after study visit

  14. Blood Pressure

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

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

  15. Heart Rate

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

    Absolute heart rate values and relative changes from baseline.

  16. Trail Making Test - Digital Cognitive Function Test

    Time frame: Baseline, 15, 32 minutes post-ingestion

    Changes in trail making test scores

  17. Sustained Attention Test - Digital Cognitive Function Test

    Time frame: Baseline, 15, 32 minutes post-ingestion

    Changes in sustained attention test scores

  18. Visual Working Memory Span Test - Digital Cognitive Function Test

    Time frame: Baseline, 15, 32 minutes post-ingestion

    Changes in visual working memory span test scores

  19. Stroop Test - Digital Cognitive Function Test

    Time frame: Baseline, 15, 32 minutes post-ingestion

    Changes in Stroop test scores

  20. Deary-Liewald Test - Digital Cognitive Function Test

    Time frame: Baseline, 15, 32 minutes post-ingestion

    Changes in Deary-Liewald test scores

  21. Cerebral Blood flow

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

    Doppler ultrasound derived blood flow in the carotid artery

Secondary outcomes

  1. Blood Glucose Concentration

    Time frame: Baseline, 15, 25, 32 minutes post-ingestion

    Changes in blood glucose concentration from capillary blood

  2. Salivary insulin concentration

    Time frame: Baseline, 15, 25, and 32 minutes post-ingestion

    Changes in salivary insulin concentration from saliva

  3. Prefrontal Cortex Oxygenation

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

    Near-infrared spectroscopy

  4. Peripheral Vascular Conductance

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

    Blood flow in the brachial artery normalized to blood pressure (mL/min/mmHg)

  5. Electromyography

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

    Electromyographic reading of muscle activity of the active muscles (glutes, hamstrings, quadriceps, and calves)

  6. Peripheral Blood Flow

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

    Doppler ultrasound derived blood flow in the brachial artery

Sponsors and collaborators

Lead sponsor

University of Southern Mississippi

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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