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

Conditions

• Fatigue, Mental
• Fatigue; Muscle, Heart

Eligibility Criteria

Sex

MALE

Age

21 Years - 40 Years

Healthy Volunteers

Accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jul 30, 2024

Status verified

Jul 2024

Primary completion

Dec 31, 2024

Completion

Dec 31, 2024

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Oral Nicotine Pouches
  Single dose 3mg oral nicotine pouch
• Experimental: Oral Caffeine Pouches
  Single dose 100mg oral caffeine pouch
• Experimental: Combination of oral nicotine and caffeine pouches
  Single simultaneous doses of a 3mg oral nicotine pouch and a 100mg oral caffeine pouch
• Placebo Comparator: Placebo
  Flavor, color, and appearance matched placebo

Primary Outcome Measure

Wingate Anaerobic Cycling Test [ Time Frame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion ]

Locations (1)

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