University of Southern Mississippi - School of Kinesiology and Nutrition
Hattiesburg, Mississippi, 39406, United States
NCT Number: NCT06529055
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.
Interested in participating?
Request Info21 year–40 year
Male
Interventional
Not applicable
Hattiesburg, Mississippi, 39406, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ingestion of a randomized oral nicotine pouch
Ingestion of a randomized oral caffeine pouch
Ingestion of a randomized oral placebo pouch
Time frame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
Changes in anaerobic cycling power output
Time frame: Baseline, 25, 32 minutes post-ingestion
Changes in blood lactate concentration from capillary blood
Time frame: Baseline, 15, 25, 32 minutes post-ingestion
Changes in salivary cortisol concentration from saliva
Time frame: Baseline, 15, 25, 32 minutes post-ingestion
Changes in interleukin-6 concentration from saliva
Time frame: Baseline, 15, 27, 40 minutes post-ingestion
Changes in salivary catecholamine concentration from saliva
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in Profile of Mood States scores (Score range: 0-60)
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in standing postural sway
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))
Time frame: Baseline, 15, 25, 32 minutes post-ingestion
Changes in subjective ratings of hunger
Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of desire to eat
Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of prospective consumption of food
Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of fullness
Time frame: 24 hours following the end of each visit
Consumption of food and beverage after study visit
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.
Time frame: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
Absolute heart rate values and relative changes from baseline.
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in trail making test scores
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in sustained attention test scores
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in visual working memory span test scores
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in Stroop test scores
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in Deary-Liewald test scores
Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Doppler ultrasound derived blood flow in the carotid artery
Time frame: Baseline, 15, 25, 32 minutes post-ingestion
Changes in blood glucose concentration from capillary blood
Time frame: Baseline, 15, 25, and 32 minutes post-ingestion
Changes in salivary insulin concentration from saliva
Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Near-infrared spectroscopy
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)
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)
Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Doppler ultrasound derived blood flow in the brachial artery
University of Southern Mississippi
Other
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